DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
This office action is in response to the amendment filed 5/4/2026. As directed by the amendment, claims 1 and 33 have been amended, and claims 19, 26, 37, 38, 40 and 41 have been cancelled. As such, claims 1, 5-7, 9-15 and 27-34 are pending in the instant application.
Applicant has amended claim 1 so as to render the previous objection thereto moot.
Applicant has amended the claims to remove unclear subject matter; the previous rejections under 35 USC 112(b)/second paragraph are withdrawn.
Applicant has cancelled claim 26, rendering the previous 112 rejections thereof moot.
Response to Arguments
Applicant's arguments filed 5/4/2026 (hereinafter “Remarks”) have been fully considered but they are not persuasive.
Applicant argues on page 9 of Remarks that amending claim 1 to recite “consisting of” means that the claim “excludes means for obstructing a nebulizer delivery port, as required by Durdon.”
The Examiner respectfully notes that the claims include both closed and open-ended phrases. In view of 37 C.F.R. 1.75(i), which sets forth that each element of a plurality of elements is to be separated by a line indentation, the closed phrase in the preamble is understood to apply to the line-indented components listed thereafter, i.e. “a container, [a lid], a nebulizer delivery port and an inhalation port,” i.e. the chamber consists of only those 4 elements, whereas the open phrase used in the description of each element (“comprising”, “including”) is understood to indicate that the 4 elements may include sub-features in addition to the ones recited by the claims. The “means for obstructing a nebulizer delivery port” of Durdon, i.e. sealing member 30, is an integral feature of the container (lid 10+cup 14) of Durdon, and thus is considered part of the container thereof, such that the container (lid 10+cup 14) of Durdon, as a whole, is still considered to anticipate a container as claimed, because the claims do not use “consisting of” language when reciting the features of the container/lid, such that the rejections in view of Durdon are maintained/updated below.
Applicant argues on page 9 of Remarks that amending claim 1 to recite “consisting of” means that the claim “excludes…a collapsible bag, as required by Lisberg.”
The Examiner again points out, as noted in the previous response to arguments, that the instant claims do not exclude the container from comprising a bag, e.g. they do not require the container walls to have any particular degree of rigidity or uncollapsibility. As such, the bag of Lisberg continues to read on a side wall as currently claimed, as maintained in the updated rejections below.
Applicant argues on page 10 of Remarks that “both Durdon and Lisberg include an essential element that is excluded from the scope of currently amended independent claim 1.”
As discussed above, the contested element of Durdon is an integral component of its container/lid, and the contested element of Lisberg corresponds to the claimed side wall of the container, such that neither Durdon or Lisberg include elements excluded from amended claim 1, because the contested elements are parts of a container, and a container is included in/required by claim 1. Therefore, the rejections in view of Durdon and Lisberg are maintained/updated below.
Applicant argues on page 11 that Melton “ascribe[s] a criticality…to the central position of the large opening” because Melton describes the opening as a central opening.
The Examiner respectfully notes that nothing in Melton indicates that the central opening needs to have an axis that aligns with the central axis of the container, and she points to e.g. Melton Fig. 4, which contains an opening located in the central region of the lid and suggests that the opening is offset to form wider rim toward the bottom as compared to the top, as well as e.g. Melton Figs. 11-12 and col. 15, lines 10-20, where the well (and thus its upper opening, which corresponds to the central opening) is explicitly described as “offset away from the drinking area,” which is on one side of the lid, i.e. the axis of the central opening is taught by be offset from the center axis of the container as a whole. She also notes that it has been held that rearranging parts of an invention involves only routine skill in the art, see MPEP 2144.04.VI.C, and that offsetting the opening would provide predictable results as discussed in the maintained/updated rejections below. Therefore, the rejections in view of Melton are maintained/updated below, where it is noted that a CIP of the previous Melton reference is now applied below because it includes an explicit discussion about keeping covers completely separate from lids, i.e. the covers are completely optional/not a required component of the containers/lids, which is considered to better address the new “consisting of” language in as far as the embodiment of Melton Fig. 9 is concerned, particularly in light of Applicant’s arguments regarding Durdon, which, while not convincing, are not applicable to Melton’s teachings regarding coverless openings.
Applicant argues on page 11 of Remarks that the claimed off-center arrangement provides particular benefits with regards to flow of aerosol in the claimed container.
In response to applicant's argument that the claimed arrangement provides particular benefits with regards to flow of aerosol in the container, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). Melton already discloses several reasons for offsetting the axis of the central opening as discussed in the maintained/updated rejections below, i.e. to provide 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 7-17 and 26-37), and it would have been readily apparent to an artisan before the effective filing date of the claimed invention that a wider lip near the egress would also predictably prevent more liquid from pouring from the larger top opening while tipped for drinking than a smaller lip near the egress and/or provide more space around the egress for a more optimal seal with the user’s lip, while still maximizing the area of the opening and/or minimizing the length of any tether. Therefore, there were already sufficient reasons to arrive at the claimed invention apart from those further recognized by Applicant.
Applicant argues on page 11 of Remarks that “Melton ascribes a criticality to its mutually exclusive design.”
The Examiner is unclear to what “mutually exclusive design” Applicant is referring. Applicant has not e.g. provided objective evidence that offsetting the central axis of the central opening of Melton in the lid of Melton Fig. 9, 10 OR 28 would render the device of Melton unusable for its intended purpose, and the Examiner maintains that Melton teaches that such an offset is desirable as discussed above and maintained in the rejections below. Moreover, as demonstrated by previously-cited Durdon, as well as Durdon (US 2005/0092749 A1) [Note: this newly-cited Durdon reference also anticipates at least claims 1 and 33, although another 102 rejection will not be given at this time for purposes of compact prosecution], offsetting the axis of an opening of a central wall of a lid (i.e. a central opening) from the central axis of a container was common in the container art before the effective filing date of the claimed invention and would have posed no problem to an artisan when implemented in Melton as disclosed/taught by Melton.
Claim Interpretation
The claims recite a chamber “consisting of” of a container (or container and lid), a nebulizer delivery port and an inhalation port, such that the claim is understood to exclude a chamber including other elements/ports, but it is noted that the container (or container and lid) is further recited as “comprising/including” certain features, such that the open-ended clauses in conjunction with the container/lid indicate that the container/lid may include sub-features in addition to those explicitly listed. It is also noted that separate/distinct elements used in conjunction with a chamber, e.g. the nebulizer device shown in instant Fig. 2 or the tube of instant Fig. 15, are not considered part of a chamber due to their detachable/separate nature from the chamber.
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+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 of (the lid+cup of Durdon Fig. 1 is a container with only two ports as claimed):
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 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 (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 of (the lid and cup of Durdon Fig. 1 is a container and a lid with only two ports as claimed):
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 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) 1, 5-7, 9-13, 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 6,374,726 B1; hereinafter “Melton”).
Regarding claim 1, Melton discloses/teaches a single dose aerosol chamber (container 12 and the lid of Fig. 9, 10 OR 28) (Figs. 1-2, 9, 10 and 28) that is fully capable of administration of a single dose of an aerosol from a nebulizer (Figs. 1-2, 9, 10 and 28, where a nebulizer is fully capable of being inserted into/fluidly connected to the larger top opening of the lid of Fig. 9, 10 or 28 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 637/237, inferred to be similar in Fig. 9, because there is nothing that would preclude this intended use), the single dose aerosol chamber consisting of (the lid of Melton Fig. 9 has an integral well and the lid of Melton Fig. 10 has an integral well and cover, such that the container+lid, i.e. chamber, comprises these elements, and Melton Fig. 28 is an embodiment of a lid without well portion or cover, any of which lids would have been inferred or, in the alternative, obvious to an artisan before the effective filing date of the claimed invention to use (alone) with a container 12 as seen in Figs. 1-2, in order to predictably provide an beverage lid, including one with less footprint/ material/manufacturing costs, i.e. that of Fig. 9, which is manufacturable/useable without the cover, or one with minimal footprint/material/manufacturing costs, i.e. that of Fig. 28, which lacks both a cover and a well, that permits access to the beverage in the container as taught by Melton, e.g. to allow the addition of condiments into the cup without removing the lid; “the lid portion can be used separately without the infuser well,” col. 5, lines 31-33, “the well may be removed…and the unit used only as a lid,” col. 6, lines 15-17, “the inner cover portion can be separately stacked and stored…for [optional] use by the user, and need not be kept [with the lid],” col. 8, lines 1-7; “lid of Figs. 28…without the presence of a cover,” col. 18, lines 38-42; col. 18, lines 20-35):
a container (container 12) comprising a base (bottom wall of the container in Fig. 1), a top wall (the lid of Fig. 9, 10 OR 28), a first central axis (up and down in Figs. 1-2) 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 (the larger top opening of the lid of Fig. 9, 10 or 28) disposed within the top wall and configured to engage a nebulizer outlet conduit (Fig. 9, 10 or 28; e.g. via insertion of the nebulizer outlet conduit into the larger top opening of the lid, as nothing would preclude this intended use); and
an inhalation port, disposed within the top wall, including a second opening (opening 637/237 [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, 10 or 28; col. 10, lines 65-66, where a user is fully capable of withdrawing gaseous fluid through opening 637/237/Fig. 9 equivalent the same as liquid fluid),
wherein nebulizer delivery port is disposed farther from the side wall than the inhalation port (Fig. 10 or 28 and inferred to be in a similar location in Fig. 9, particularly in view of Figs. 1-2 and 12),
wherein the first opening is larger than the second opening (Fig. 10 or 28/Fig. 9 equivalent, particularly in view of Figs. 1-2 and 12),
wherein the nebulizer delivery port includes a second central axis (up and down in Figs. 1-2 when using the lid of Fig. 9, 10 OR 28) extending through the first opening (larger top opening), the inhalation port includes a third central axis (up and down in Figs. 1-2 when using the lid of Fig. 9, 10 or 28) extending through the second opening (opening 637/237/Fig. 9 equivalent), and the first central axis is separate (offset) from and parallel to both the second central axis and the third central axis (Figs. 1-2 when using the lid of Fig. 10 or 28; where the axes of the cup as a whole and those through the center of the openings are all vertically oriented/aligned, and see Figs. 11-12 or 28, where the larger opening is depicted/taught in Figs. 11-12 and suggested in Fig. 28 to be offset from center and the opening 637/237 is clearly off to one side: “the center of the bottom of the well is offset away from the drinking area,” col. 17, lines 7-10, which thus discloses/suggests the upper opening of the well to be similarly offset, i.e. as clearly shown in Fig. 12, in order to provide a symmetrical well/opening for easy manufacture, e.g. by stamping of an offset, symmetrical shape/opening, and which offset would have been obvious to an artisan before the effective filing date of the claimed invention to ensure/include in any of the lids of Figs. 9, 10 OR 28 to predictably keep liquid from pouring from the larger top opening while tipped for drinking by providing a larger lip on the drinking side of the larger opening and/or to provide more space around the small opening for a more optimal seal with the user’s lip and/or to provide 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 7-17 and 26-37)), 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 when using the lid of Fig. 9, 10 or 28; 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 5, Melton discloses/teaches the single dose aerosol chamber of claim 1, wherein Melton further discloses/teaches wherein the inhalation port (opening 637/237) is disposed within a raised portion (the upper annular rim) of the top wall (Fig. 10 or 28, inferred to be a similar location in Fig. 9).
Regarding claim 6, Melton discloses/teaches the single dose aerosol chamber of claim 1, wherein Melton further discloses/teaches wherein the inhalation port (opening 637/237) is oblong (Fig. 10 or 28, inferred to be similar in Fig. 9) (col. 10, lines 66-67).
Regarding claim 7, Melton discloses/teaches the single dose aerosol chamber of claim 1, wherein Melton further discloses/teaches wherein the nebulizer delivery port is off-centre with respect to the first central axis of the container and adjacent the side wall (Figs. 9, 10-12 or 28 in view of the discussion of claim 1 above).
Regarding claim 9, Melton discloses/teaches the single dose aerosol chamber of claim 1, wherein modified Melton further teaches wherein the inhalation port (opening 637/237, inferred to be a similar location in Fig. 9) is adjacent the side wall on a side of the top wall opposed to the nebulizer delivery port (e.g. Figs. 10-12 or 28 in view of the discussion of claim 1 above).
Regarding claim 10, Melton discloses/teaches the single dose aerosol chamber of claim 1, wherein Melton further discloses wherein the container is of an insulating material (col. 10, lines 48-50).
Regarding claims 11 and 12, Melton discloses/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 ounces, col. 10, lines 36-37; where 8 oz is 236 mL and 20 oz is 591 mL).
Regarding claim 13, Melton discloses/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 33, Melton discloses/teaches a single dose aerosol chamber (container 12 and the lid of Fig. 9, 10 OR 28) (Figs. 1-2, 9, 10 and 28) that is fully capable of administration of a single dose of an aerosol from a nebulizer (Figs. 1-2, 9, 10 and 28, where a nebulizer is fully capable of being inserted into/fluidly connected to the larger top opening of the lid of Fig. 9, 10 or 28 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 637/237, inferred to be similar in Fig. 9, because there is nothing that would preclude this intended use), the single dose aerosol chamber consisting of (the lid of Melton Fig. 9 has an integral well and the lid of Melton Fig. 10 has an integral well and cover, such that the lid/chamber comprises these elements, and Melton Fig. 28 is an embodiment of a lid without well portion or cover, any of which lids would have been inferred or, in the alternative, obvious to an artisan before the effective filing date of the claimed invention to use (alone) with a container 12 as seen in Figs. 1-2, in order to predictably provide an beverage lid, including one with less footprint/material/manufacturing costs, i.e. that of Fig. 9, which is manufacturable/useable without the cover, or one with minimal footprint/material/ manufacturing costs, i.e. that of Fig. 28, which lacks both a cover and a well, that permits access to the beverage in the container as taught by Melton, e.g. to allow the addition of condiments into the cup without removing the lid; “the lid portion can be used separately without the infuser well,” col. 5, lines 31-33, “the well may be removed…and the unit used only as a lid,” col. 6, lines 15-17, “the inner cover portion can be separately stacked and stored…for [optional] use by the user, and need not be kept [with the lid],” col. 8, lines 1-7; “lid of Figs. 28…without the presence of a cover,” col. 18, lines 38-42; col. 18, lines 20-35):
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) perpendicular to the base, and a side wall (sidewall portions 14) (Fig. 1);
a lid (the lid of Fig. 9, 10 OR 28) configured to form a top wall of the container (Figs. 1-2 and 9, 10 or 28), the lid comprising a central wall (the groove 535/bottom thereof of Fig. 9; comprising trough 728 and/or wall 734 in Figs. 10-13; the upright wall of the larger top opening of the lid of Fig. 28 and/or wherein it would have been obvious to an artisan before the effective filing date of the claimed invention for the lid of Fig. 28 to include the groove 535/bottom thereof from Fig. 9, in order to provide the predictable result of providing for the possibility of securable interacting with an optional cover) and a raised rim (outer margin portion 634/annular panel 232) surrounding the central wall (Figs. 9-12 or 28/Fig. 28 in view of Fig. 9);
a nebulizer delivery port including a first opening (the larger top opening of the lid of Fig. 9, 10 or 28) disposed within the central wall of the lid and configured to engage a nebulizer outlet conduit (Fig. 9, 10 or 28; e.g. via insertion of the nebulizer outlet conduit into the larger top opening of the lid, as nothing would preclude this intended use); and
an inhalation port, disposed within the raised rim of the lid, including a second opening (opening 637/237, Fig. 9 equivalent) for user inhalation of contents of the container (Figs. 1-2 and 9, 10 or 28; col. 11, lines 18-19, where a user is fully capable of withdrawing gaseous fluid through opening 637/237/Fig. 9 equivalent the same as liquid fluid),
wherein nebulizer delivery port is disposed farther from the side wall than the inhalation port (Fig. 10 or 28 and inferred to be in a similar location in Fig. 9, particularly in view of Figs. 1-2 and 12),
wherein the first opening is larger than the second opening (Fig. 10 or 28/Fig. 9 equivalent, particularly in view of Figs. 1-2 and 12),
wherein the nebulizer delivery port includes a second central axis (up and down in Figs. 1-2 when using the lid of Fig. 9, 10 or 28) extending through the first opening (larger top opening), the inhalation port includes a third central axis (up and down in Figs. 1-2 when using the lid of Fig. 9, 10 or 28) extending through the second opening (opening 637/237/Fig. 9 equivalent), and the first central axis parallel to both the second central axis and the third central axis (Figs. 1-2 when using the lid of Fig. 9, 10 or 28; where the axes of the cup as a whole and those through the center of the openings 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 when using the lid of Fig. 9, 10 or 28; 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, 10 or 28; removable lid, col. 4, line 36; removable infuser, col. 10, lines 35-43).
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) 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) 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 (top end cap 28+bag 44+ bottom end cap 46) (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 similar to the way it administers a single dose of aerosol from an MDI, e.g. by connecting the nebulizer to collar 36 and delivering a single dose into the chamber for inhalation through opening 30), the chamber (28+44+46) consisting of:
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, e.g. the same way as adapter 40 is engaged); 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 the first opening (at 36) is larger than the second opening (30) (Fig. 11),
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 Lisberg further discloses wherein the inhalation port (opening 30) is oblong (Fig. 11).
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.
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter: while previously-cited Bruin (US 2017/0232212 A1) teaches using something similar to a disposable coffee cup as an inhaler spacer, the arrangement in Bruin does not retain the functionality of the coffee cup because the inlet and outlet are on opposite sides/the top and bottom of the cup, such that if Applicant were to positively recite a nebulizer in combination with the elements of claim 33 and amend claims 27-32 to depend from claim 33 [Note: claim 33 was not rejected in view of Lisberg], this would define claims 27-34 over the art of record because the combination of a container/lid with a raised rim and only two top/lid ports positioned as claimed, e.g. as taught by Melton, is not taught to be used in combination with a nebulizer/to have aerosol delivered thereinto to be delivered therefrom.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHRYN E DITMER whose telephone number is (571)270-5178. The examiner can normally be reached M 7:30a-3:30p, T/Th 8:30a-2:30p, W 11:30a-4:30p, F 1-4p ET.
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/KATHRYN E DITMER/Primary Examiner, Art Unit 3785
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