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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/3/2025 has been entered.
Response to Amendment
This office action is in response to the amendment filed 11/3/2025. As directed by the amendment, claims 1 and 33 have been amended, and claims 16, 20-25 and 39 have been cancelled. As such, claims 1, 5-7, 9-15, 19, 26-34, 37, 38, 40 and 41 are pending in the instant application, wherein claims 38, 40 and 41 remain withdrawn as non-elected by original presentation.
Response to Arguments
Applicant's arguments filed 11/3/2025 (hereinafter “Remarks”) have been fully considered but they are not persuasive.
On page 11 of Remarks, regarding the rejections in view of Melton, Applicant asserts that “[t]he scope of currently amended independent claim 1…excludes a beverage infuser.”
The Examiner fails to see how claim 1 necessarily excludes a beverage infuser. The phrase “consisting essentially of” is semi-open-ended/permits additional elements to be present. So long as a beverage infuser permits airflow into a container, the intended use regarding aerosol delivery is still possible; therefore, “the basic and novel characteristics” (see Claim Interpretation section below) are not materially affected by the perforated well of Melton. As such, the embodiments of Melton with a beverage infuser continue to read on the claimed invention as discussed in the updated rejections below.
On page 11 of Remarks, regarding the rejections in view of Melton, Applicant states “every embodiment of the beverage infuser of Melton “includes a well portion…[it] is thus an essential component of the invention of Melton.”
The Examiner disagrees with Applicant’s misrepresentation of Melton. Melton explicitly discloses embodiments without a well portion, see e.g. Figs. 27-29 and associated Brief Descriptions, and teaches the use of “the lid alone without the infuser well,” in col. 6, lines 60-62; therefore, the well portion is not an essential component of the invention of Melton.
On page 11 of Remarks, regarding the rejections in view of Melton, with regards to “consisting essentially of,” Applicant misrepresents the standard, erroneously stating that “components [that would] materially change the characteristics of the claimed invention” are excluded, and asserting the introduction of a beverage infuser “would provide the claimed invention with additional structure and functionality…that the claimed invention otherwise would not possess and would therefore materially change the characteristics of the claimed invention.”
MPEP 2111.03.III. states: “The transitional phrase "consisting essentially of" limits the scope of a claim to the specified materials or steps "and those that do not materially affect the basic and novel characteristic(s)" (bold emphasis added) of the claimed invention. The addition of functionality, so long as it does not materially affect/preclude the basic and novel characteristics/functionality of the claimed invention, is not excluded by the phrase “consisting essentially of”. Therefore, since the well portion of Melton is perforated and thus permits airflow therethrough and into the container, the intended use regarding aerosol delivery is still possible in the presence of the well portion, such that, while additional functionality may be provided by the well portion, “the basic and novel characteristics” of the claimed invention are not materially affected by its presence. Moreover, Melton teaches that the well portion need not be included as discussed above, which renders this line of argument moot with regards to the alternative 103 rejections below.
On page 12 of Remarks, regarding the rejections in view of Melton, Applicant argues that the central axis of the large opening of Melton Figs. 1-2 and 9 is “one and the same with the central axis of the container.”
The Examiner respectfully notes that there is no criticality to this positioning in Melton, and it has been held that rearranging parts of an invention involves only routine skill in the art, see MPEP 2144.04.VI.C. Indeed, Melton itself, e.g. Figs. 4, 12-13 and 19-22 and col. 15, lines 10-20, teaches wherein the central axis of the large, above-the-well opening is separate (i.e. offset) from the center of the lid (the large opening is off-center towards the top in Fig. 4 and off-center towards to the right in Figs. 12/19), and Melton col. 15, lines 29-31 teaches the obviousness of increasing the width of the rim at the location of the egress opening, e.g. opening 37. Therefore, shifting the positioning of the large opening in Melton Figs. 1-2 and 9 such that its central axis is not “one and the same with the central axis of the container,” e.g. to space the well and associated opening away from the egress and/or to provide a larger rim width on the side of the lid with the egress, is taught by Melton and obvious for the reasons discussed in the updated, 103 rejection of claim 1 in view of Melton below.
On page 14 of Remarks, regarding the rejections in view of Durdon, Applicant states that “[t]he scope of currently amended independent claim 1…excludes an obstructed nebulizer delivery port and/or means for obstructing a nebulizer delivery port…Durdon includes a sealing member 30 for obstructing.”
The Examiner fails to see how claim 1 excludes “means for obstructing a nebulizer delivery port”/the sealing member 30 of Durdon, and the meaning/scope of an “unobstructed” port is unclear as discussed in the 112 section below. The phrase “consisting essentially of” is semi-open-ended/permits additional elements to be present, and the limitations regarding the container include the open-ended language of “comprising” and “including.” So long as a port permits airflow into a container (at any point in time), the intended use regarding aerosol delivery is possible; therefore, “the basic and novel characteristics” (see Claim Interpretation section below) are not materially affected by the presence of a detachable or moveable obstruction/cover, e.g. the sealing member 30 of Durdon, when said cover is not use. Indeed, the instant specification as originally filed shows the nebulizer port (temporarily) obstructed by the nebulizer itself in Figs. 2-4, and on page 20, lines 12-15 indicates that other temporary obstructing means, e.g. a cover or flap, can be present (as these would not preclude the intended use regarding aerosol delivery so long as they are not in a closed position for introduction of the aerosol into the chamber), such that temporary obstruction is not considered excluded by the claims. As such, the sealing member comprised by the container of Durdon is not excluded by the instant claims and it is clearly shown as not obstructing the opening 28 in Durdon Figs. 2-3; the rejections in view of Durdon are updated below.
On page 14 of Remarks, Applicant references para [0089] (of the instant PGPub), which discloses a valve or flap as discussed above, then confusingly concludes “[a]ccordingly, the inclusion of an obstruction of the nebulizer delivery port, or means for obstructing the nebulizer delivery port, would therefore materially change the characteristics of the claimed invention.”
The Examiner reiterates that the standard for evaluating the phrase “consisting essentially of” is not whether or not “characteristics are changed/added,” but rather, whether or not the basic and novel characteristic(s) are materially affected, see MPEP 2111.03.III. The inclusion of a valve/moveable flap (or removable cover) adds functionality (prevention of backflow) without taking away the underlying functionality of permitting delivery (inflow) into a container, i.e. the basic and novel characteristic(s) are unaffected by the presence of a valve/moveable flap/removable cover. As such, Durdon discloses the claimed limitations as discussed in the updated rejections below.
On page 16 of Remarks, regarding the rejections in view of Lisberg, Applicant asserts that “[t]he scope of currently amended independent claim 1…excludes a collapsible bag.”
The Examiner fails to see how claim 1 excludes a collapsible bag. There is nothing in the claims that requires the container to have a particular degree of rigidity or uncollapsibility.
On page 16 of Remarks, regarding the rejections in view of Lisberg, Applicant argues that “a collapsible bag as taught by Lisberg would provide the claimed invention with additional structure and functionality…that the claimed invention otherwise would not possess and would therefore materially change the characteristics of the claimed invention.”
The Examiner reiterates that the standard for evaluating the phrase “consisting essentially of” is not that “characteristics are changed/added,” but rather, whether or not the basic and novel characteristic(s) are materially affected, see MPEP 2111.03.III. The instant claims do not exclude the container from comprising a bag, e.g. they do not require the container to have a particular degree of rigidity or uncollapsibility. Since the bag of Lisberg is fully capable of (and indeed, disclosed as) providing the claimed functionality regarding delivery of aerosol into the container and withdrawal of said aerosol from the container, Lisberg meets the contested limitations as maintained in the updated rejections below.
On page 18 of Remarks, regarding the teachings of Fink to modify Lisberg to have the inlet point straight down, Applicant argues that “the Examiner must show that the result of the claimed combination of A and B would have been obvious.”
The Examiner respectfully notes that this was shown: Fink expressly teaches that it was known in the inhalation spacer art before the effective filing date of the claimed invention that an aerosol inlet may be angled with regards to a container lid upper surface, i.e. as disclosed by Lisberg, or point straight down as discussed in the maintained/updated rejections below, and pointing an aerosol inlet straight down would predictably orient the aerosol plume introduced therethrough so as to avoid the upright sides of the container. Thus, sufficient motivation and predictability exists, and the rejections in view of Lisberg and Fink are maintained in the updated rejections below.
Applicant argues on pages 18-19 of Remarks, regarding the modification of Lisberg by Fink, that ““the first central axis being parallel to both the second central axis and the third central axis” contributes to the nebulizer delivery port and the inhalation port being in the same plane…[for] effective flow of aerosol” and that “[d]evoid of the automated dispensing context [of the instant invention]…Lisberg and Fink provide no motivation for combining their teaching to achieve such a result.”
First, in response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the ports are in the same plane or that the aerosol delivery in the method claims is automated) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Moreover, even if the “same plane” limitation were included in the claims, it is noted that the base reference of Lisberg already discloses both port openings on the upper surface of a flat lid, i.e. in the same plane, such that this would not be a point of differentiation. Second, it is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. MPEP 2144.IV. Fink expressly teaches that it was known in the inhalation spacer art before the effective filing date of the claimed invention that an aerosol inlet may be angled with regards to a container lid upper surface, i.e. as disclosed by Lisberg, or point straight down, where pointing straight down would provide the predictable results discussed above and maintained in the updated rejections below. These results are achievable independent of any (unclaimed) automation context.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1, line 10 should read “port are unobstructed”
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, 5-7, 9-15, 19, 26-34 and 37 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 claims 1 and 33 (and thus their dependent claims), it is unclear in the claims, particularly in view of the instant specification, what is the meaning/scope of ports that “are unobstructed.” Is this intended to be read as an in-use limitation inferring that the ports are configured to allow airflow therethrough at some point, given that the specification discloses the nebulizer delivery port is occluded/obstructed during intended operation, e.g. Figs. 2-4, and see also page 20, lines 12-15, which indicate that a filter, cover or flap may be attached to/obstruct the ingress, at least at certain points in time? Or is it intended to be a structural limitation, indicating that, as best understood, there is nothing within the ports themselves, i.e. they are open/empty spaces, e.g. excluding the filter of page 20, lines 12-15? For purposes of examination, either interpretation will be applied.
Claim 26 recites the limitation "the baffle" in line 2 [see 112d rejection below regarding claim 26 being interpreted to depend from claim 1 for purposes of compact prosecution]. There is insufficient antecedent basis for this limitation in the claim.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 26 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 26 depends from claim 25, which has been cancelled. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements. For purposes of compact prosecution, claim 26 will be considered to depend on claim 1.
Claim Interpretation
Per MPEP 2111.03.III., the phrase “consisting essentially of” limits the scope of the claim to the specified elements “and those that do not materially affect the basic and novel characteristic(s)” of the claimed invention, wherein, for the purposes of searching for and applying prior art under 35 U.S.C. 102 and 103, absent a clear indication in the specification or claims of what the basic and novel characteristics actually are, "consisting essentially of" will be construed as equivalent to "comprising." As best understood from specification as originally filed, the “basic and novel characteristic(s)” are the claimed chamber forming of a generally enclosed hollow space with an ingress and egress, see the lidded container of instant Figs. 2-4 and 11, which permits an aerosol to be introduced into the container through the ingress and inhaled out of the container through the egress, see e.g. page 6, lines 7-11 of the instant specification. Therefore, any additional structures disclosed by prior art that do not permanently prevent a lidded chamber from providing this functionality are considered within the scope of/not excluded by the claims.
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.
Claim(s) 1, 5-7, 9, 10, 13, 33 and 34 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Durdon (US 7,175,042 B2; hereinafter “Durdon”).
Regarding claim 1, Durdon discloses a single dose aerosol chamber (lid 10 and cup 14) (Fig. 1) that is fully capable of administration of a single dose of an aerosol from a nebulizer (Fig. 1, where a nebulizer is fully capable of being inserted into/fluidly connected to opening 28 then used to dispense a single dose of an aerosol into cup 14, and a user subsequently able to inhale the dispensed aerosol dose through access port 26, because there is nothing that would preclude this intended use), the chamber consisting essentially of (the lid and cup of Durdon Fig. 1 meet the limitations below and form a generally enclosed hollow space with an ingress and egress (i.e. substantially similar to the container of instant Figs. 2-4), which is fully capable of permitting an aerosol to be introduced into the container through opening 28 and inhaled out of the container through opening 26 as discussed above, which are understood to be the essential characteristics/properties of the claimed invention):
a container (Fig. 1) comprising a base (the bottom of cup 14), a top wall (lid 10), a first central axis perpendicular to the base (up and down in Figs. 1 and 3), and a sidewall (the vertical wall of cup 14) extending between the base and the top wall (Fig. 1),
a nebulizer delivery port including a first opening (opening 28) disposed within the top wall and configured to engage a nebulizer outlet conduit (Figs. 2-3; e.g. via insertion of the nebulizer outlet conduit into opening 28, as nothing would preclude this application); and
an inhalation port (access port 26), disposed within the top wall, including a second opening (the through-opening that defines port 26) for user inhalation of contents of the container (Figs. 2-3; col. 6, lines 24-31, where a user is fully capable of withdrawing gaseous fluid through port 26 the same as liquid fluid),
wherein, as best understood, both the nebulizer delivery port and the inhalation port are unobstructed (air can flow through either opening when the lid is arranged as depicted in Figs. 1-3, and see Figs. 2-3, where there is nothing within openings 26 and 28, i.e. they are open/empty spaces);
wherein nebulizer delivery port is disposed farther from the side wall than the inhalation port (Figs. 1-3),
wherein the first opening (28) is larger than the second opening (26) (port 26 is substantially smaller in size than…opening 28, col. 6, lines 25-27),
wherein the nebulizer delivery port includes a second central axis (up and down in Fig. 3) extending through the first opening, the inhalation port includes a third central axis (up and down in Fig. 3) extending through the second opening, and the first central axis is separate from and parallel to the second central axis and the third central axis (Figs. 1 and 3, where the axes of the cup as a whole and those through the center of the openings 26 and 28 are all vertically oriented/aligned and offset from each other), and
wherein the container is configured for receiving aerosol via the nebulizer delivery port and mixing the aerosol with gas in the container for delivery via the inhalation port (Figs. 2-3; in as far as the container of Durdon is fully capable of serving an inhaler spacer because it is a generally enclosed hollow space with an ingress and egress (i.e. substantially similar to the container of instant Figs. 2-4), Durdon is configured as claimed).
Regarding claim 5, Durdon discloses the single dose aerosol chamber of claim 1, wherein Durdon further discloses wherein the inhalation port (26) is disposed within a raised portion of the top wall (Figs. 2-3).
Regarding claim 6, Durdon discloses the single dose aerosol chamber of claim 1, wherein Durdon further discloses wherein the inhalation port (26) is oblong (Fig. 2).
Regarding claim 7, Durdon discloses the single dose aerosol chamber of claim 1, wherein Durdon further discloses wherein the nebulizer delivery port (28) is off-centre with respect to the first central axis of the container and adjacent the side wall (Figs. 1-3).
Regarding claim 9, Durdon discloses the single dose aerosol chamber of claim 1, wherein Durdon further discloses wherein the inhalation port (26) is adjacent the side wall on a side of the top wall opposed to the nebulizer delivery port (Figs. 1-3).
Regarding claim 10, Durdon discloses the single dose aerosol chamber of claim 1, wherein Durdon further discloses wherein the container is of an insulating material (col. 1, lines 29-30).
Regarding claim 13, Durdon discloses the single dose aerosol chamber of claim 1, wherein Durdon further discloses wherein the side wall is curved and tapers to narrow downwardly towards the base (Fig. 1).
Regarding claim 33, Durdon discloses a single dose aerosol chamber (comprising lid 10 and cup 14) (Fig. 1) that is fully capable of administration of a single dose of an aerosol from a nebulizer (Fig. 1, where a nebulizer is fully capable of being inserted into/fluidly connected to opening 28 then dispensing a single dose of an aerosol into cup 14, and a user subsequently able to inhale the dispensed aerosol dose through access port 26, because there is nothing that would preclude this intended use), the single dose aerosol chamber consisting essentially of (the lid and cup of Durdon Fig. 1 meet the limitations below and form a generally enclosed hollow space with an ingress and egress (i.e. substantially similar to the container of instant Figs. 2-4), which is fully capable of permitting an aerosol to be introduced into the container through opening 28 and inhaled out of the container through opening 26 as discussed above, which are understood to be the essential characteristics/properties of the claimed invention):
a container (Fig. 1) comprising a base (the bottom of cup 14), a first central axis perpendicular to the base (up and down in Figs. 1 and 3), and a sidewall (the vertical wall of cup 14) (Fig. 1);
a lid (lid 12) configured to form a top wall of the container (Fig. 1), the lid comprising a central wall (at cover portion 18 in Fig. 2) and a raised rim surrounding the central wall (Figs. 2-3);
a nebulizer delivery port including a first opening (opening 28) disposed within the central wall of the lid and configured to engage a nebulizer outlet conduit (Figs. 2-3; e.g. via insertion of the nebulizer outlet conduit into opening 28, as nothing would preclude this application); and
an inhalation port (access port 26), disposed within the raised rim of the lid (Figs. 2-3), including a second opening (the through-opening that defines port 26) for user inhalation of contents of the container (col. 6, lines 24-31, where a user is fully capable of withdrawing gaseous fluid through port 26 the same way as liquid fluid),
wherein, as best understood, both the nebulizer delivery port and the inhalation port are unobstructed (air can flow through either opening when the lid is arranged as depicted in Figs. 1-3, and see Figs. 2-3, where there is nothing within openings 26 and 28, i.e. they are open/empty spaces);
wherein nebulizer delivery port is disposed farther from the side wall than the inhalation port (Figs. 1-3),
wherein the first opening (28) is larger than the second opening (26) (port 26 is substantially smaller in size than…opening 28, col. 6, lines 25-27),
wherein the nebulizer delivery port includes a second central axis (up and down in Fig. 3) extending through the first opening, the inhalation port includes a third central axis (up and down in Fig. 3) extending through the second opening, and the first central axis is parallel to the second central axis and the third central axis (Figs. 1 and 3, where the axes of the cup as a whole and those through the center of the openings 26 and 28 are all vertically oriented/aligned), and
wherein the container is configured for receiving aerosol via the nebulizer delivery port and mixing the aerosol with gas in the container for delivery via the inhalation port (Figs. 2-3; in as far as the container of Durdon is fully capable of serving an inhaler spacer because it is a generally enclosed hollow space with an ingress and egress (i.e. substantially similar to the container of instant Figs. 2-4), Durdon is configured as claimed).
Regarding claim 34, Durdon discloses the single dose aerosol chamber of claim 33, wherein Durdon further discloses wherein the lid is removable (Figs. 1-2; col. 6, lines 1-5).
Claim Rejections - 35 USC § 102/103
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.
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.
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) 33 and 34 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 Melton (US 5,913,964; hereinafter “Melton”).
Regarding claim 33, Melton discloses a single dose aerosol chamber (container 12 and infuser 10/510) (Figs. 1-2 and 9) that is fully capable of administration of a single dose of an aerosol from a nebulizer (Figs. 1-2 and 9, where a nebulizer is fully capable of being inserted into/fluidly connected to top opening 39 of well portion 38/the top opening of well portion 538 that is bounded by groove 535 then used to dispense a single dose of an aerosol into container 12, and a user subsequently able to inhale the dispensed aerosol dose through opening 37 [with a similar opening inferred to be present in the embodiment of Fig. 9 in order for it to function similar to the other embodiments per col. 11, lines 63-67], because there is nothing that would preclude this intended use), the single dose aerosol chamber consisting essentially of (the container and infuser of Melton Figs. 1-2 and 9 are taught to meet the limitations below and form a generally enclosed hollow space with an ingress and egress (i.e. substantially similar to the container of instant Figs. 2-4), which is fully capable of permitting an aerosol to be introduced into the container through the large opening of Melton and inhaled out of the container through the small opening as discussed above, which are understood to be the essential characteristics/properties of the claimed invention; moreover, even if the well portion and/or cover were excluded, Melton discloses embodiments of lids without well portions (see e.g. Figs. 27-29 and associated Brief Descriptions; “the lid alone without the infuser well,” col. 6, lines 60-62) as well as without covers (Figs. 24-26; “the cover attachment portion has been eliminated,” col. 15, lines 60-61), such that it would have been obvious to an artisan before the effective filing date of the claimed invention, in the alternative, to exclude the well portion and/or cover in the embodiments of Fig. 1-2 and 9, in order to provide the predictable results of permitting direct access to the beverage (Melton col. 6, lines 60-62) and/or reducing the footprint/material/manufacturing costs of the lid by not forming and/or attaching the well portion and/or cover):
a container (container 12) comprising a base (bottom wall of the container in Fig. 1), a first central axis (up and down in Figs. 1-2 and 9) perpendicular to the base, and a side wall (sidewall portions 14) (Fig. 1);
a lid (infuser 10/510) configured to form a top wall of the container (Figs. 1-2 and 9), the lid comprising a central wall (the bump out at the top of wall 40 in Fig. 2/the bottom of groove 535 in Fig. 9) and a raised rim (comprising surface panel 32) surrounding the central wall (Figs. 1-2 and 9);
a nebulizer delivery port including a first opening (top opening 39 of well portion 38/the top opening of well portion 538 that is bounded by groove 535) disposed within the central wall of the lid and configured to engage a nebulizer outlet conduit (Figs. 1-2 and 9; e.g. via insertion of the nebulizer outlet conduit into opening 39/Fig. 9 equivalent, as nothing would preclude this intended use); and
an inhalation port, disposed within the raised rim of the lid, including a second opening (opening 37 [with a similar opening inferred to be present in the embodiment of Fig. 9 in order for it to function similar to the other embodiments per col. 11, lines 63-67]) for user inhalation of contents of the container (Figs. 1-2 and 9; col. 11, lines 18-19, where a user is fully capable of withdrawing gaseous fluid through opening 37 the same as liquid fluid),
wherein, as best understood, both the nebulizer delivery port and the inhalation port are unobstructed (air can flow through either opening when the lid is arranged as depicted in Figs. 1 and 9, OR see alternatively e.g. Fig. 28, and see also Figs. 1-2 and 9, where there is nothing in the top opening 39/the top opening of well portion 538 that is bounded by groove 535 when cover 550 is not inserted therein, i.e. as depicted in Fig. 9, or in opening 37/Fig. 9 equivalent, i.e. they are open/empty spaces);
wherein nebulizer delivery port is disposed farther from the side wall than the inhalation port (Figs. 1-2, and see also e.g. Fig. 4),
wherein the first opening is larger than the second opening (Figs. 1-2, and see also e.g. Fig. 4),
wherein the nebulizer delivery port includes a second central axis (up and down in Figs. 1-2 and 9) extending through the first opening, the inhalation port includes a third central axis (up and down in Figs. 1-2) extending through the second opening, and the first central axis is parallel to both the second central axis and the third central axis (Figs. 1-2 and 9; where the axes of the cup as a whole and those through the center of the openings 37 and 39 [and their counterparts in Fig. 9] are all vertically oriented/aligned), and
wherein the container is configured for receiving aerosol via the nebulizer delivery port and mixing the aerosol with gas in the container for delivery via the inhalation port (Figs. 1-2 and 9; in as far as the container of Melton is fully capable of serving an inhaler spacer because it is a generally enclosed hollow space with an ingress and egress (i.e. substantially similar to the container of instant Figs. 2-4), Melton is configured as claimed).
Regarding claim 34, Melton discloses/teaches the single dose aerosol chamber of claim 33, wherein the lid is removable (e.g. Figs. 2 and 9; removable infuser, col. 8, lines 38-39).
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.
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, 5-7, 9-13, 16, 20, 25 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Melton.
Regarding claim 1, Melton discloses a single dose aerosol chamber (comprising container 12 and infuser 10/510) (Figs. 1-2 and 9) that is fully capable of administration of a single dose of an aerosol from a nebulizer (Figs. 1-2 and 9, where a nebulizer is fully capable of being inserted into/fluidly connected to top opening 39 of well portion 38/the top opening of well portion 538 that is bounded by groove 535 then used to dispense a single dose of an aerosol into container 12, and a user subsequently able to inhale the dispensed aerosol dose through opening 37 [with a similar opening inferred to be present in the embodiment of Fig. 9 in order for it to function similar to the other embodiments per col. 11, lines 63-67], because there is nothing that would preclude this intended use), the single dose aerosol chamber consisting essentially of (the container and infuser of Melton Figs. 1-2 and 9 are taught to meet the limitations below and form a generally enclosed hollow space with an ingress and egress (i.e. substantially similar to the container of instant Figs. 2-4), which is fully capable of permitting an aerosol to be introduced into the container through the large opening of Melton and inhaled out of the container through the small opening, which are understood to be the essential characteristics/properties of the claimed invention; moreover, even if the well portion and/or cover were excluded, Melton discloses embodiments of lids without well portions (see e.g. Figs. 27-29 and associated Brief Descriptions; “the lid alone without the infuser well,” col. 6, lines 60-62) as well as without covers (Figs. 24-26; “the cover attachment portion has been eliminated,” col. 15, lines 60-61), such that it would have been obvious to an artisan before the effective filing date of the claimed invention, in the alternative, to exclude the well portion and/or cover in the embodiments of Fig. 1-2 and 9, in order to provide the predictable results of permitting direct access to the beverage (Melton col. 6, lines 60-62) and/or reducing the footprint/material/manufacturing costs of the lid by not forming and/or attaching the well portion and/or cover):
a container (container 12) comprising a base (bottom wall of the container in Fig. 1), a top wall (comprising annular top surface panel 32/similar top panel in Fig. 9 comprising groove 535), a first central axis (up and down in Figs. 1-2 and 9) perpendicular to the base, and a side wall (sidewall portions 14) extending between the base and the top wall (Fig. 1);
a nebulizer delivery port including a first opening (top opening 39 of well portion 38/the top opening of well portion 538 that is bounded by groove 535) disposed within the top wall and configured to engage a nebulizer outlet conduit (Figs. 1-2 and 9; e.g. via insertion of the nebulizer outlet conduit into opening 39/Fig. 9 equivalent, as nothing would preclude this intended use); and
an inhalation port, disposed within the top wall, including a second opening (opening 37 [with a similar opening inferred to be present in the embodiment of Fig. 9 in order for it to function similar to the other embodiments per col. 11, lines 63-67]) for user inhalation of contents of the container (Figs. 1-2 and 9; col. 11, lines 18-19, where a user is fully capable of withdrawing gaseous fluid through opening 37 the same as liquid fluid),
wherein, as best understood, both the nebulizer delivery port and the inhalation port are unobstructed (air can flow through either opening when the lid is arranged as depicted in Figs. 1 and 9, and see alternatively e.g. Fig. 28, and see also Figs. 1-2 and 9, where there is nothing in the top opening 39/the top opening of well portion 538 that is bounded by groove 535 when cover section 62/cover 550 is not inserted therein, i.e. as depicted in Figs. 1 and 9, or in opening 37/Fig. 9 equivalent, i.e. they are open/empty spaces);
wherein nebulizer delivery port is disposed farther from the side wall than the inhalation port (Figs. 1-2, and see also e.g. Fig. 4),
wherein the first opening is larger than the second opening (Figs. 1-2, and see also e.g. Fig. 4),
wherein the nebulizer delivery port includes a second central axis (up and down in Figs. 1-2 and 9) extending through the first opening, the inhalation port includes a third central axis (up and down in Figs. 1-2) extending through the second opening, and the first central axis is parallel to both the second central axis and the third central axis (Figs. 1-2 and 9; where the axes of the cup as a whole and those through the center of the openings 37 and 39 [and their counterparts in Fig. 9] are all vertically oriented/aligned), and
wherein the container is configured for receiving aerosol via the nebulizer delivery port and mixing the aerosol with gas in the container for delivery via the inhalation port (Figs. 1-2 and 9; in as far as the container of Melton is fully capable of serving an inhaler spacer because it is a generally enclosed hollow space with an ingress and egress (i.e. substantially similar to the container of instant Figs. 2-4), Melton is configured as claimed).
Melton is silent regarding wherein the first central axis in Figs. 1-2 and 9 is separate (i.e. offset) from both the second central axis and the third central axis. However, it has been held that rearranging parts of an invention involves only routine skill in the art, see MPEP 2144.04.VI.C. The instantly claimed arrangement would have been obvious to try from a finite number of locations for the larger opening, with the expected result of a suitable opening for accessing the well while sufficiently accommodating the application of a user’s lip around the egress opening, e.g. opening 37, on the top of the lid. Indeed, Melton teaches that it was known in the art/to solve the probem of locating openings in container lids before the effective filing date of the claimed invention to include wherein the first central axis is separate (i.e. offset) from both the second central axis and the third central axis, see e.g. Figs. 4, 12-13 and 19-22 and col. 15, lines 10-20, where the central axis of the large, above-the-well opening is separate (i.e. offset) from the center of the lid (the large opening is off-center towards the top in Fig. 4 and off-center towards to the right in Figs. 12/19) and where col. 15, lines 29-31 teaches the obviousness of increasing the width of the rim at the location of the egress opening, e.g. opening 37, which would thus render obvious offsetting the above-the-well opening accordingly. Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention to modify the lid of Melton Figs. 1-2 and 9 to include wherein the first central axis is separate (i.e. offset) from both the second central axis and the third central axis as taught by Melton e.g. Figs. 4/12/19, in order to provide the predictable result of more space around the small opening for a more optimal seal with the user’s lip and/or a smoother flow of fluid to the small opening and/or to keep the infuser contents out of the fluid when tipped (Melton col. 15, lines 10-20 and 29-40).
Regarding claim 5, Melton teaches the single dose aerosol chamber of claim 1, wherein Melton further discloses/teaches wherein the inhalation port (37/Fig. 9 equivalent) is disposed within a raised portion of the top wall (Figs. 1-2 and 9).
Regarding claim 6, Melton teaches the single dose aerosol chamber of claim 1, wherein Melton further discloses/teaches wherein the inhalation port (37/Fig. 9 equivalent) is oblong (Figs. 1-2 and 9) (col. 9, lines 1-3).
Regarding claim 7, Melton teaches the single dose aerosol chamber of claim 1, wherein modified Melton further teaches wherein the nebulizer delivery port is off-centre with respect to the first central axis of the container and adjacent the side wall (e.g. Fig. 4/19/21).
Regarding claim 9, Melton teaches the single dose aerosol chamber of claim 1, wherein modified Melton further teaches wherein the inhalation port is adjacent the side wall on a side of the top wall opposed to the nebulizer delivery port (e.g. Fig. 4/19/21).
Regarding claim 10, Melton teaches the single dose aerosol chamber of claim 1, wherein Melton further discloses wherein the container is of an insulating material (col. 8, lines 51-53).
Regarding claims 11 and 12, Melton teaches the single dose aerosol chamber of claim 1, wherein Melton further discloses wherein the container/chamber volume is in the range of 100mL to 600mL, specifically in the range of 150mL to 400mL (drinking cup of moderate capacity, such as 8-20 oz, col. 8, lines 39-40; where 8 oz is 236 mL and 20 oz is 591 mL).
Regarding claim 13, Melton teaches the single dose aerosol chamber of claim 1, wherein Melton further discloses wherein the side wall (14) is curved and tapers to narrow downwardly towards the base (Fig. 1).
Regarding claim 26, Melton teaches the single dose aerosol chamber of claim [1], wherein, as best understood, Melton further discloses [a] baffle (wall 41/540 of well 38/538 with openings 42/slots shown in Fig. 9) (Figs. 2 and 9) that is tubular, extending inwardly from the nebulizer delivery port (Figs. 2 and 9).
Claim(s) 11, 12, 14 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Durdon as applied to claim 1 above, and further in view of Bailey (US 2012/0152968 A1; hereinafter “Bailey”).
Regarding claims 11 and 12, Durdon discloses the single dose aerosol chamber of claim 1, but Durdon is silent regarding the size of the container, such that Durdon is silent regarding wherein the container/chamber volume is in the range of 100mL to 600mL, specifically in the range of 150mL to 400mL. However, optimization of ranges of parameters within prior art ranges or through routine experimentation is not sufficient to patentably distinguish the invention over the prior art, see MPEP § 2144.05, and Bailey demonstrates that it was very well known in the container art before the effective filing date of the claimed invention for a container such as that of Durdon (Bailey Figs. 13-13a) to have a volume in the range of 100mL to 600mL, specifically in the range of 150mL to 400mL (a standard 12 oz (355mL) hot beverage cup, para [0066]). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention for Durdon to include wherein the container/chamber volume is in the range of 100mL to 600mL, specifically in the range of 150mL to 400mL as taught by Bailey, in order to provide the predictable result of a standard sized cup.
Regarding claims 14 and 15, Durdon discloses the single dose aerosol chamber of claim 1, but Durdon is silent regarding particular dimensions for opening 28, such that modified Durdon is silent regarding wherein the nebulizer delivery port has an area in the range of 30 mm2 to 700 mm2, specifically in the range of 30 mm2 to 120 mm2. However, optimization of ranges of parameters within prior art ranges or through routine experimentation is not sufficient to patentably distinguish the invention over the prior art, see MPEP § 2144.05, and Bailey demonstrates that it was very well known in the container lid art before the effective filing date of the claimed invention for a container lid such as that of Durdon (Bailey Figs. 13-13a) to have an access port (aperture 58) (Fig. 1) an area in the range of 30 mm2 to 700 mm2, specifically in the range of 30 mm2 to 120 mm2 (aperture 58 is circular, having a diameter…10 mm [which provides an area of ~78.5 mm], para [0072]). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention for Durdon to include wherein the nebulizer delivery port/opening 28 has an area in the range of 30 mm2 to 700 mm2, specifically in the range of 30 mm2 to 120 mm2 as taught by Bailey, in order to provide the predictable result of a suitably-sized aperture for addition of condiments (Durdon col. 1, lines 6-10) as well as access for straws (Bailey para [0028]) and/or flavor enhancement (Bailey paras [0020-21] and [0036]) and/or to permit assessing the level of liquid in the container (Bailey para [0032]).
Claim(s) 14 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Melton as applied to claim 1 above, and further in view of Bailey (US 2012/0152968 A1; hereinafter “Bailey”).
Regarding claims 14 and 15, Melton teaches the single dose aerosol chamber of claim 1, but Melton is silent regarding particular dimensions for openings above the wells, such that modified Melton is silent regarding wherein the nebulizer delivery port has an area in the range of 30 mm2 to 700 mm2, specifically in the range of 30 mm2 to 120 mm2. However, optimization of ranges of parameters within prior art ranges or through routine experimentation is not sufficient to patentably distinguish the invention over the prior art, see MPEP § 2144.05, and Bailey demonstrates that it was very well known in the container art before the effective filing date of the claimed invention for a container lid such as that of Melton (Bailey Figs. 13-13a) to have an access port (aperture 58) (Fig. 1) an area in the range of 30 mm2 to 700 mm2, specifically in the range of 30 mm2 to 120 mm2 (aperture 58 is circular, having a diameter…10 mm [which provides an area of ~78.5 mm], para [0072]). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention for modified Melton to include wherein the nebulizer delivery port/opening 28 has an area in the range of 30 mm2 to 700 mm2, specifically in the range of 30 mm2 to 120 mm2 as taught by Bailey, in order to provide the predictable result of a suitably-sized aperture for addition of tea leaves, hot water or condiments (Melton col. 6, lines 54-62) as well as access for straws (Bailey para [0028]) and/or flavor enhancement (Bailey paras [0020-21] and [0036]) and/or to access/permit assessing the level of liquid in the container (Melton col. 6, lines 61-62; Bailey para [0032]).
Claim(s) 19 and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Melton OR Durdon as applied to claim 1 above, and further in view of Tang (CN 105480552 A; hereinafter “Tang”, wherein the citations below refer to the translation provided with the Office Action mailed 2/20/2025).
Regarding claims 19 and 37, Melton teaches OR Durdon discloses the single dose aerosol chamber of claims 1 and 33, but modified Melton OR Durdon is silent regarding wherein there is an anti-microbial coating on an external surface of the chamber/an antimicrobial coating on an external surface configured to prevent cross-contamination. However, Tang demonstrates that it was known in the container art before the effective filing date of the claimed invention for a container similar to that of Melton/Durdon (Tang Fig. 1) to include an anti-microbial coating on an external surface of the chamber/an antimicrobial coating on an external surface (the outer surface of the box body is further provided with an antibiotic coating, second-to-last full para on page 1). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention for modified Melton OR Durdon to include wherein there is an anti-microbial coating on an external surface of the chamber/an antimicrobial coating on an external surface as taught by Tang, which is configured to prevent cross-contamination by virtue of the antibiotic functionality of the coating/as an intended result that flows directly from the material properties of the coating, as discussed on page 20, lines 10-11 of the instant specification, in order to provide the predictable result of preventing germ transmission when the container is e.g. passed from one person to another (Tang abstract).
Claim(s) 1, 5-7, 9, 10, 13, and 27-32 are rejected under 35 U.S.C. 103 as being unpatentable over Lisberg (US 2016/0256641 A1; hereinafter “Lisberg”) in view of Spector (US 4,119,097; hereinafter “Spector”) and Fink et al. (US 2011/0108025 A1; hereinafter “Fink”).
Regarding claim 1, Lisberg discloses a single dose aerosol chamber (delivery device 20) (Fig. 1) that is fully capable of administration of a single dose of an aerosol from a nebulizer (Figs. 1 and 18; para [0038], where the chamber is fully capable of administering a single dose of aerosol from a nebulizer in the same way it administers a single dose of aerosol from an MDI, e.g. by connecting the nebulizer to adapter 40 (or directly to collar 36) and delivering a single dose into the chamber for inhalation via mouthpiece 22), the chamber consisting essentially of (device of modified Lisberg meets the limitations below and forms a generally enclosed hollow space with an ingress and egress (i.e. similar to the container of instant Figs. 2-4), which permit an aerosol to be introduced into the container through opening 36 and inhaled out of the container through opening 30, which are understood to be the essential characteristics/properties of the claimed invention):
a container comprising a base (bottom end cap 46), a top wall (the top surface of top end cap 28), a first central axis perpendicular to the base (up and down in Fig. 1), and a sidewall (the wall of bag 44 and the vertical lip of cap 28) extending between the base and the top wall (Fig. 17);
a nebulizer delivery port (collar 36) including a first opening (the opening at the bottom of the collar) disposed within the top wall (Figs. 11-12) and configured to engage a nebulizer outlet conduit (Figs. 1-2; e.g. via insertion into collar 36, the same way as adapter 40 is engaged, or by inserting a nebulizer outlet conduit into the opening of adapter 40); and
an inhalation port, disposed within the top wall, including a second opening (opening 30) for user inhalation of contents of the container (Fig. 11; paras [0028] and [0038]),
wherein, as best understood, both the nebulizer delivery port and the inhalation port are unobstructed (Figs. 1 and 11, where openings 30 and 36 are open/empty spaces (before the mouthpiece and MDI adaptor are attached), and wherein there are direct airflow pathways that extend through openings 30 and 36 after the mouthpiece and MDI adapter are attached);
wherein the first opening (at 36) is larger than the second opening (30),
wherein the nebulizer delivery port includes a second central axis (angled in Fig. 1) extending through the first opening (at 36) (Fig. 1), the inhalation port (30) includes a third central axis (up and down in Fig. 1) extending through the second opening (Fig. 1), and the first central axis is separate from both the second central axis (Fig. 1) and the third central axis and parallel to the third central axis (Fig. 1, where the axes of the spacer as a whole and that through the center of the opening 30 are both vertically oriented/aligned),
wherein the container is configured for receiving aerosol via the nebulizer delivery port (Figs. 1, 12 and 17; para [0038]) and mixing the aerosol with gas in the container for delivery via the inhalation port (Figs. 1 and 17; para [0038]).
Lisberg is silent regarding wherein nebulizer delivery port is disposed farther from the side wall than the inhalation port. However, it has been held that rearranging parts of an invention involves only routine skill in the art, see MPEP 2144.04.VI.C, and a change in size is generally recognized as being within the level of ordinary skill in the art, see MPEP 2144.04.IV.A. The instantly claimed arrangement would have been obvious to try from a finite number of relative locations and desired sizes for the two ports and the lid (with a larger diameter lid providing a larger volume spacer, and/or different sizes for the inlet and outlet depending on the desired outflow and/or component compatibility), and Spector demonstrates that it was known in the inhaler spacer art before the effective filing date of the claimed invention for the inlet (aperture through which the right-moving arrows in Fig. 7 pass) of a spacer (the bulbus shape to the right in Fig. 7) to be positioned more centrally/farther from the side wall than an outlet (either of the apertures through which the left-moving arrows in Fig. 7 pass) of the spacer. There is nothing in Lisberg that would prevent the use of the instantly claimed configuration, and it appears that Lisberg would perform equally well with such a modification; therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention to modify Lisberg such that nebulizer delivery port is disposed further from the side wall than the inhalation port through routine experimentation and as taught by Spector and allowing for a degree of manufacturing tolerance that accommodates the axes being offset, in order to provide the predictable result of a suitably-sized lid and/or inlet/outlet, where the inlet is generally/more centrally positioned/farther from the side wall than the outlet, so as to direct the aerosol plume more towards the middle of the spacer so as to avoid the aerosol plume contacting the sides thereof (which would reduce the dosage and foul the spacer), particularly when the inlet and outlet are parallel as disclosed by Spector Fig. 7 and taught below.
Lisberg is silent regarding wherein the first central axis [which is parallel to the third axis] is [also] parallel to the second central axis. However, Lisberg ascribes no criticality to the angle of the collar 36, and Fink teaches that it was known in the nebulizer spacer art before the effective filing date of the claimed invention for the first central axis (up and down in Fig. 3) to either be angled with regards to the second central axis of a nebulizer delivery port (nebulizer inlet port 24) (Fig. 3) OR wherein the first central axis is parallel to the second central axis (nebulizer 14 slip fits into the nebulizer port 24, para [0110]; nebulizer 14 may be offset from, and/or angled with respect to the central axis…[or] may be generally coaxial therewith, para [0123]). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention for modified Lisberg to include wherein the first central axis is parallel to the second central axis [and thus wherein the first central axis is parallel to both the second central axis and the third central axis] as taught by Fink, in order to provide the predictable result of angling the inlet of Lisberg directly downward so as to avoid the aerosol plume contacting the sides of the spacer (which would reduce the dosage and foul the spacer).
Regarding claim 5, Lisberg in view of Spector and Fink teaches the single dose aerosol chamber of claim 1, wherein Fink further educates modified Lisberg to include wherein the inhalation port is disposed within a raised portion of the top wall (Fink Fig. 3, where the top wall/lid has a frusto-conical/raised portion and both inlet and outlet ports are on that portion), in order to provide the predictable result of the lid of modified Lisberg being frusto-conically shaped with the inlet and outlet thereon so as to funnel gas within the chamber towards the outlet during use.
Regarding claim 6, Lisberg in view of Spector and Fink teaches the single dose aerosol chamber of claim 1, wherein a change in shape is generally recognized as being within the level of ordinary skill in the art, see MPEP 2144.04.IV.B, and Fink further educates modified Lisberg to include wherein the inhalation port is oblong (see the opening of mouthpiece 102 of Fink in Fig. 1), in order to provide the predictable result of a mouthpiece suited to be positioned within the mouth without pressure points (i.e. at the top and bottom of a circular port) between the teeth.
Regarding claim 7, Lisberg in view of Spector and Fink teaches the single dose aerosol chamber of claim 1, wherein modified Lisberg teaches wherein the nebulizer delivery port is off-centre with respect to the first central axis of the container and adjacent the side wall (Lisberg Figs. 1, 2, and 12 in view Spector Fig. 7 and the discussion above regarding claim 1 and allowing for a degree of manufacturing tolerance).
Regarding claim 9, Lisberg in view of Spector and Fink teaches the single dose aerosol chamber of claim 8, wherein the inhalation port is adjacent the side wall on a side of the top wall opposed to the nebulizer delivery port (Lisberg Figs. 1, 2, and 12 in view of the discussion above regarding claim 1 in view Spector Fig. 7 and the discussion above regarding claim 1 and allowing for a degree of manufacturing tolerance).
Regarding claim 10, Lisberg in view of Spector and Fink teaches the single dose aerosol chamber of claim 1, wherein Lisberg further discloses wherein the container is of an insulating material (para [0030]).
Regarding claim 13, Lisberg in view of Spector and Fink teaches the single dose aerosol chamber of claim 1, wherein a change in shape is generally recognized as being within the level of ordinary skill in the art, see MPEP 2144.04.IV.B, and wherein Fink further educates modified Lisberg to include wherein the side wall is curved and tapers to narrow downwardly towards the base (Fink Figs. 3-4), in order to provide the predictable result of optimizing mixing of ambient air and the aerosol and/or minimizing deposition of aerosol within the spacer (Fink para [0096]).
Regarding claim 27, Lisberg in view of Spector and Fink teaches the use of the single dose aerosol chamber of claim 1, for delivery of an aerosol to a user, by delivering aerosol into the container through the nebulizer delivery port and user inhalation of the aerosol through the inhalation port (Lisberg para [0038] in view of the discussion of claim 1 above).
Regarding claims 28-30, Lisberg in view of Spector and Fink teaches the use of claim 27, wherein Fink further educates modified Lisberg to include wherein the time period between delivery of aerosol through the nebulizer coupling port and inhalation is less than 60 seconds, 15 seconds or 10 seconds (an aerosolized dose may require about 10 to 60 seconds to administer…[d]uring administration, the patient typically breathes multiple times, such as about 10-40 times per minute, thus multiple inspiration[s]…take place while the medicament is being aerosolized and administered, Fink para [0129], i.e. the time between delivery of aerosol through the nebulizer port and the first inhalation is less than 10-60 seconds; see also Fink para [0137], where a single inspiration empties the chamber/the plume will not settle for about 2-5 seconds, i.e. about 2-5 seconds is the time between delivery of the aerosol through the nebulizer port and the single inhalation), in order to provide the predictable result of ensuring that a complete dose is delivered and also that the aerosol does not have time to settle onto the walls of the container, which would result in reduced dosage and fouling of the spacer.
Regarding claim 31, Lisberg in view of Spector and Fink teaches the use of claim 27, but modified Lisberg is silent regarding wherein the dose has a volume in the range of 0.5mL to 0.25mL. However, optimization of ranges of parameters within prior art ranges or through routine experimentation is not sufficient to patentably distinguish the invention over the prior art, see MPEP § 2144.05, and Fink discloses wherein the dose has a volume in the range of about 0.05 mL to 50 mL (para [0017]). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention for the use of modified Lisberg to include wherein the dose has a volume in the range of 0.5mL to 0.25mL, because this range is within the suitable/known range taught by Fink and depending on the particular medicament and/or size of patient being treated, in order to provide an effective dose of medicament, where use of a dose within the lower range of Fink as instantly claimed would have been obvious with more potent medicaments and/or smaller patients.
Regarding claim 32, Lisberg in view of Spector and Fink teaches the use of claim 27, wherein Fink further educates modified Lisberg to include wherein the aerosol is a vaccine (Fink paras [0015], [0156]), in order to provide the predictable result of vaccination using an aerosolized medicament and spacer.
Claim(s) 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Lisberg in view of Spector and Fink as applied to claim 1 above, and further in view of Mistry et al. (WO 2019/237151 A1; hereinafter “Mistry”).
Regarding claims 11 and 12, Lisberg in view of Spector and Fink teaches the single dose aerosol chamber of claim 1, but Lisberg is silent regarding dimensions, such that modified Lisberg is silent regarding wherein the container/chamber volume is in the range of 100mL to 600mL, i.e. 150mL to 400mL. However, it has been held that where the general conditions of the claims are disclosed in the prior art, finding the optimum or workable ranges involves only routine skill in the art, see MPEP 2144.05.II.A, and Mistry demonstrates that it was well known in the aerosol holding chamber/inhaler spacer art before the effective filing date of the claimed invention for an aerosol holding chamber (chamber 130) to have a volume in the range of 100mL to 600mL, i.e. 150mL to 400mL (Fig. 10; the volume of the chamber is…most preferably 150 mL to 400mL, para [0040]). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention for the volume of the container/chamber of modified Lisberg to be in the range of 100mL to 600mL, i.e. 150mL to 400mL, through routine experimentation and as taught by Mistry, in order to provide the predictable result of an aerosol holding chamber/inhaler spacer that is suitably sized for delivery of a dose of aerosolized medicament into the lungs of a patient, e.g. a child (Mistry para [0042]).
Claim(s) 14 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Lisberg in view of Spector and Fink as applied to claim 1 above, and further in view of Stein (US 2003/0196654 A1; hereinafter “Stein”).
Regarding claims 14 ad 15, Lisberg in view of Spector and Fink teaches the single dose aerosol chamber as claimed in claim 1, but modified Lisberg is silent regarding the size of the nebulizer port, such that they are silent regarding wherein the nebulizer delivery port has an area in the range of 30 mm2 to 700 mm2, i.e. 30 mm2 to 120 mm2. However, optimization of ranges of parameters within prior art ranges or through routine experimentation is not sufficient to patentably distinguish the invention over the prior art, see MPEP § 2144.05, and Stein demonstrates that it was well known in the aerosol holding chamber/inhaler spacer art before the effective filing date of the claimed invention for an aerosol inlet port to have an area in the range of 30 mm2 to 700 mm2, i.e. 30 mm2 to 120 mm2 (inlet port of diameter 1.0 cm or 0.75 cm, paras [0029] and [0031], where Fig. 2 depicts the inlet port 220 as circular, such that the area is thus pi*(0.5d)^2, so ~78mm2 or ~44mm2). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention for the nebulizer delivery port of modified Lisberg to comprise an area in the range of 30 mm2 to 700 mm2, i.e. 30 mm2 to 120 mm2 through routine experimentation and as taught by Stein, in order to provide the predictable result of an nebulizer delivery port that is sufficiently sized to accept a standard nebulizer outlet conduit/conduct a sufficient amount of aerosol into the holding/spacer chamber for effective treatment.
Claim(s) 19 is rejected under 35 U.S.C. 103 as being unpatentable over Lisberg in view of Spector and Fink as applied to claim 1 above, and further in view of Beller (WO 2016/082900 A1; hereinafter “Beller”).
Regarding claim 19, Lisberg in view of Spector and Fink teaches the single dose aerosol chamber as claimed in claim 1, but modified Lisberg is silent regarding wherein there is an anti-microbial coating on an external surface of the chamber. However, Beller demonstrates that it was well known in the inhaler art before the effective filing date of the claimed invention for an inhaler component to have an anti-microbial coating on an external surface (second full paragraph on page 11 of the translation provided with the Office Action mailed 3/4/2024). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention for there to be an anti-microbial coating on an external surface of the chamber of modified Lisberg as taught by Beller, in order to provide the predictable result of a chamber that can be handled with minimal germ transfer (Beller, middle of page 5 of the translation provided with the Office Action mailed 3/4/2024).
Claim(s) 26 is rejected under 35 U.S.C. 103 as being unpatentable over Lisberg in view of Spector and Fink as applied to claim [1] above, and further in view of Power et al. (US 2010/0089395 A1; hereinafter “Power”).
Regarding claim 26, Lisberg in view of Spector and Fink teaches the single dose aerosol chamber as claimed in claim [1], but modified Lisberg is silent regarding a baffle that is tubular, extending inwardly from the nebulizer delivery port. However, Power teaches that it was known in the aerosol holding chamber/inhaler spacer art before the effective filing date of the claimed invention to provide a baffle (skirt 25) (Fig. 2) for droplet size filtering (skirt 25…acts as a baffle to retard particles above a certain size, para [0077]), wherein the baffle is tubular, extending inwardly from the nebulizer delivery port (in which aerosol generator 9 is positioned) (Fig. 2). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention for modified Lisberg to include a baffle for size filtering, wherein the baffle is tubular, extending inwardly from the nebulizer delivery port as taught by Power, in order to provide the predictable result of a means for ensuring that the aerosol particles delivered to the user are small enough to be transported (Power para [0077]) to the lungs for effective treatment.
Conclusion
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/KATHRYN E DITMER/ Primary Examiner, Art Unit 3785