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 Amendments
The Amendment filed 8/11/2025 has been entered. Claims 1, 4, 6-8, and 13-14 were amended, claims 3, 11-12, 15-17, and 20 were canceled, and claims 21-27 were new. Thus, claims 1-2, 4-10, 13-14, 18-19, and 21-27 are pending in the application. However, new claims 26-27 are being withdrawn from consideration as being directed to a non-elected invention, as detailed below.
Election/Restrictions
Newly submitted claims 26-27 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: claims 1-2, 4-10, 13-14, 18-19, and 21-25 are directed to a product and claims 26-27 are directed to a process of using the product. Please note that claim 27 recites a dependency on the method of claim 25, which the Examiner believes is a typo that should read --claim 26-- as claim 25 is not directed to a method. The inventions are patentably distinct since the product as claimed can be used in a materially different process (see MPEP 806.05(h)). The product has a dome opening to fluidly mate with a flange output port and an inhaler device, but does not recite placing the animal’s head through that same dome opening as is recited for the process, and so can have a different means to receive the animal’s head. For example, the product could have a different opening for the animal’s head to fit through, or the whole animal might be enclosed in the dome.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 26-27 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 13 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 13, the limitation “a diameter of the dome” in lines 1-2 is confusing, as it is unclear whether this is meant to be the same as or different from “a dome diameter” recited in claim 1. For the purposes of examination, they will be interpreted as the same limitation.
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.
Claims 21 and 23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hickmann (US 4,577,628).
Regarding claim 21, Hickmann discloses an inhaler system for surrounding an entirety of an animal's head and for administering medication thereby (dome 1 surrounds the entire head of the animal; animal is provided with nebulized medicament) (Figs. 1-3; col. 4, lines 43-46), the inhaler system comprising:
a dome including a dome inner volume and a dome opening passing from outside the dome to the dome inner volume (dome 1 is hollow, and so has an inner volume; hole 5 in the dome 1 provides air from outside dome 1 to the inside of dome 1 via an adapter 14) (Figs. 1-3; col. 2, lines 33-39; col. 3, lines 41-47; col. 4, lines 34-40, 50-57), the dome opening including an opening diameter that is 95% or less than a diameter of the dome (hole 5 has a diameter that is less than 95% of a diameter of the dome) (Figs. 1-3);
a flange including a flange input port, a flange output port and a flange inner volume extending between the flange input port and the flange output port (adapter 14 has an input port at one end and an output port at the other end, with a volume of space in-between, in order to provide air from the nebulizer device 16 to the dome 1) (Fig. 3; col. 4, lines 50-57);
wherein the flange input port is adapted to receive an output end of an inhaler device (one end of the adapter 14 having a port receives the base 17 of the nebulizer device 16) (Fig. 3; col. 4, lines 34-40, 50-57, 66-67);
and wherein the flange output port is adapted to releasably fluidly mate with the dome opening (the other end of the adapter 14 having a port fluidly mated to the opening 5 of the dome 1; as the use of the adapter 14 or plug 7 in hole 5 can be switched, the adapter 14 would be releasable from the hole 5) (Fig. 3; col. 4, lines 50-57, 66-67; col. 6, lines 1-5).
Regarding claim 23, Hickmann discloses further comprising: at least one breathing hole located in the dome and adapted to allow air to pass from outside the dome inner volume to inside the dome inner volume (holes 12 in the dome 1 would allow for air to pass in and out between the outside environment and inner volume of dome 1) (Fig. 2; col. 4, lines 13-17).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-2, 4-5, and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Hickmann in view of Giulianotti et al. (US 2016/0107006 A1).
Regarding claim 1, Hickmann discloses an inhaler system for administering medication to an animal (animal is provided with nebulized medicament) (Figs. 1-3; col. 4, lines 43-46), the animal including an animal head with a head diameter (animal’s head has a diameter) (Fig. 1), the inhaler system comprising:
a dome including a dome diameter that is greater than the head diameter (dome 1 has a diameter larger than the animal’s head diameter) (Fig. 1; col. 2, lines 33-39), a dome inner volume (dome 1 is hollow and so has an inner volume) (Fig. 1; col. 2, lines 33-39) and a dome opening passing from outside the dome to the dome inner volume (hole 5 in the dome 1 provides air from outside dome 1 to the inside of dome 1 via an adapter 14) (Figs. 1-3; col. 3, lines 41-47; col. 4, lines 34-40, 50-57), the dome adapted to surround an entirety of the animal head (dome 1 surrounds the animal’s whole head) (Fig. 1; col. 2, lines 33-39);
a flange including a flange input port, a flange output port and a flange inner volume extending between the flange input port and the flange output port (adapter 14 has an input port at one end and an output port at the other end, with a volume of space in-between, in order to provide air from the nebulizer device 16 to the dome 1) (Fig. 3; col. 4, lines 50-57);
wherein the flange input port is adapted to receive an output end of an inhaler device (one end of the adapter 14 having a port receives the base 17 of the nebulizer device 16) (Fig. 3; col. 4, lines 34-40, 50-57, 66-67);
and wherein the flange output port is adapted to releasably fluidly mate with the dome opening (the other end of the adapter 14 having a port fluidly mated to the opening 5 of the dome 1; as the use of the adapter 14 or plug 7 in hole 5 can be switched, the adapter 14 would be releasable from the hole 5) (Fig. 3; col. 4, lines 50-57, 66-67; col. 6, lines 1-5).
Hickmann does not disclose the dome is spherical.
However, Giulianotti teaches a helmet for providing oxygen and/or anesthetic gas (Giulianotti; abstract) wherein the dome is spherical (helmet has a substantially spherical shape) (Giulianotti; Figs. 1-3; para. [0018]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Hickmann dome to be spherical, as taught by Giulianotti, for the purpose of providing the dome with a shape that is anatomically shaped to help support nape and neck of a patient (Giulianotti; para. [0014]).
Regarding claim 2, the modified Hickmann teaches further comprising: at least one breathing hole located in the dome and adapted to allow air to pass from outside the dome inner volume to inside the dome inner volume (holes 12 in the dome 1 would allow for air to pass in and out between the outside environment and inner volume of dome 1) (Hickmann; Fig. 2; col. 4, lines 13-17).
Regarding claim 4, the modified Hickmann teaches wherein when the flange input port receives the output end of the inhaler device (one end of the adapter 14 having a port receives the base 17 of the nebulizer device 16) (Hickmann; Fig. 3; col. 4, lines 34-40, 50-57, 66-67) and the flange output port releasably mates with the dome opening (the other end of the adapter 14 having a port fluidly mated to the opening 5 of the dome 1; as the use of the adapter 14 or plug 7 in hole 5 can be switched, the adapter 14 would be releasable from the hole 5) (Hickmann; Fig. 3; col. 4, lines 50-57, 66-67; col. 6, lines 1-5), the output end of the inhaler device is in fluid communication with the dome inner volume (the base 17 of the nebulizer device 16 is in fluid communication with the dome 1 inner volume to provide air and nebulized medicament to the inside of dome 1) (Hickmann; Fig. 3; col. 4, lines 50-57, 66-67).
Regarding claim 5, the modified Hickmann teaches wherein the dome is transparent (transparent plastic dome 1) (Hickmann; col. 3, lines 34-35).
Regarding claim 9, the modified Hickmann teaches wherein a shape of the flange output port corresponds to a shape of the dome opening (the other end of the adapter 14 having a port connects to the opening 5 of the dome 1, and so they would have corresponding shapes) (Hickmann; Fig. 3; col. 4, lines 50-57, 66-67).
Claims 6 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Hickmann in view of Giulianotti as applied to claim 1 above, and further in view of Asai et al. (WO 2008/111255 A1, see attached translation).
Regarding claim 6, the modified Hickmann teaches the invention as previously claimed, but does not teach wherein a portion of the dome surrounding the dome opening includes an outer surface curvature, and the flange output port includes an inner surface curvature that corresponds to the outer surface curvature.
However, Asai teaches an inhalation aid (Asai; abstract) wherein a portion of the dome surrounding the dome opening includes an outer surface curvature, and the flange output port includes an inner surface curvature that corresponds to the outer surface curvature (tubular convex portion 164 is cylindrical and has an outer surface curvature, and it defines the relay pipe side opening 163a; the connection part 155 with standing wall portion 155b is a hollow cylinder, and so has an inner surface curvature that corresponds to the outer surface curvature of the tubular convex portion 164) (Asai; Figs. 1-5; translation page 19, second paragraph; translation page 20, last two paragraphs; translation page 22, second paragraph).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Hickmann dome and flange output port such that a portion of the dome surrounding the dome opening includes an outer surface curvature, and the flange output port includes an inner surface curvature that corresponds to the outer surface curvature, as taught by Asai, for the purpose of preventing the pipe or flange from entering the internal space of the dome, and thereby helping to eliminate hygiene problems and prevent secondary infections (Asai; translation page 11, last paragraph).
Regarding claim 10, the modified Hickmann teaches wherein a diameter of the flange output port is greater than a diameter of the dome opening (the connection part 155 with a standing wall portion 155b surrounds the tubular convex portion 164 defining a relay pipe side opening 163a, and so its diameter is greater) (Asai; Figs. 1-5; translation page 19, second paragraph; translation page 20, last two paragraphs; translation page 22, second paragraph).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Hickmann in view of Giulianotti as applied to claim 1 above, and further in view of London et al. (US 2011/0214671 A1).
Regarding claim 7, the modified Hickmann teaches the invention as previously claimed, but does not teach wherein the flange output port is formed as a portion of a hemispherical dome.
However, London teaches an inhaler assembly (London; abstract) wherein the flange output port is formed as a portion of a hemispherical dome (spacer second half 70 is hollow and substantially conical, thereby forming a portion of a hemispherical dome) (London; Fig. 8; para. [0050]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Hickmann flange output port to be formed as a portion of a hemispherical dome, as taught by London, for the purpose of helping to facilitate the delivery of the drug into the airways of an animal (London; para. [0016]).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Hickmann in view of Giulianotti as applied to claim 1 above, and further in view of Deaton (US 3,552,391).
Regarding claim 13, as best understood, the modified Hickmann teaches the invention as previously claimed, but does not teach wherein a diameter of the dome is 5"-8".
However, Deaton teaches a chamber to supply oxygen to a patient (Deaton; abstract) a diameter of the dome is 5"-8" (circular chamber has a diameter of approximately 8 inches) (Deaton; Figs. 1-2; col. 4, lines 35-37).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Hickmann dome diameter to be 5”-8”, as taught by Deaton, for the purpose of providing a specific suitable dome or chamber diameter which one of ordinary skill in the art could reasonably expect to perform suitably well (Deaton; col. 4, lines 35-37).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Hickmann in view of Giulianotti as applied to claim 1 above, and further in view of Dhuper et al. (US 2007/0283954 A1).
Regarding claim 18, the modified Hickmann teaches the invention as previously claimed, but does not teach wherein the flange input port is pliable.
However, Dhuper teaches an aerosol inhalation system (Dhuper; abstract) wherein the flange input port is pliable (inner surface of adapter 400 side wall 402 has a compressible seal member 430) (Dhuper; Figs. 9-9A; para. [0074]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Hickmann flange input port to be pliable, as taught by Dhuper, for the purpose of providing an improved fit and seal for the connection (Dhuper; para. [0074]).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Hickmann in view of Giulianotti as applied to claim 1 above, and further in view of Goldman et al. (US 2022/0347421 A1).
Regarding claim 19, the modified Hickmann teaches the invention as previously claimed, but does not teach further comprising a gas tube receiving nipple configured with the dome.
However, Goldman teaches an apparatus for administering inhaled drugs (Goldman; abstract) including a gas tube receiving nipple configured with the dome (oxygen nipple 110 on mask 100) (Goldman; Fig. 2; para. [0054]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Hickmann dome to include a gas tube receiving nipple configured with the dome, as taught by Goldman, for the purpose of allowing for the simultaneous administration of oxygen and aerosol medication, which is often beneficial in emergency response or maintenance treatment of significant respiratory disorders (Goldman; para. [0002]).
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Hickmann as applied to claim 21 above, and further in view of Giulianotti.
Regarding claim 22, Hickmann discloses the invention as previously claimed, but does not disclose wherein the dome is spherical.
However, Giulianotti teaches a helmet for providing oxygen and/or anesthetic gas (Giulianotti; abstract) wherein the dome is spherical (helmet has a substantially spherical shape) (Giulianotti; Figs. 1-3; para. [0018]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Hickmann dome to be spherical, as taught by Giulianotti, for the purpose of providing the dome with a shape that is anatomically shaped to help support nape and neck of a patient (Giulianotti; para. [0014]).
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Hickmann as applied to claim 21 above, and further in view of Asai.
Regarding claim 24, Hickmann discloses the invention as previously claimed, but does not disclose wherein a portion of the dome surrounding the dome opening includes an outer surface curvature, and the flange output port includes an inner surface curvature that corresponds to the outer surface curvature.
However, Asai teaches an inhalation aid (Asai; abstract) wherein a portion of the dome surrounding the dome opening includes an outer surface curvature, and the flange output port includes an inner surface curvature that corresponds to the outer surface curvature (tubular convex portion 164 is cylindrical and has an outer surface curvature, and it defines the relay pipe side opening 163a; the connection part 155 with standing wall portion 155b is a hollow cylinder, and so has an inner surface curvature that corresponds to the outer surface curvature of the tubular convex portion 164) (Asai; Figs. 1-5; translation page 19, second paragraph; translation page 20, last two paragraphs; translation page 22, second paragraph).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Hickmann dome and flange output port such that a portion of the dome surrounding the dome opening includes an outer surface curvature, and the flange output port includes an inner surface curvature that corresponds to the outer surface curvature, as taught by Asai, for the purpose of preventing the pipe or flange from entering the internal space of the dome, and thereby helping to eliminate hygiene problems and prevent secondary infections (Asai; translation page 11, last paragraph).
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Hickmann as applied to claim 21 above, and further in view of London.
Regarding claim 25, Hickmann discloses the invention as previously claimed, but does not disclose wherein the flange output port is formed as a portion of a hemispherical dome.
However, London teaches an inhaler assembly (London; abstract) wherein the flange output port is formed as a portion of a hemispherical dome (spacer second half 70 is hollow and substantially conical, thereby forming a portion of a hemispherical dome) (London; Fig. 8; para. [0050]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Hickmann flange output port to be formed as a portion of a hemispherical dome, as taught by London, for the purpose of helping to facilitate the delivery of the drug into the airways of an animal (London; para. [0016]).
Allowable Subject Matter
Claims 8 and 14 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 8, the prior art of record does not disclose nor sufficiently teach
wherein the flange input port is located at an apex of the flange output port.
Regarding claim 14, the prior art of record does not disclose nor sufficiently teach wherein a diameter of the dome opening is 3"-6".
Response to Arguments
Applicant's arguments filed 8/11/2025 have been fully considered but they are not persuasive.
On pages 8-9 in the “Claim Rejections - 35 USC 112” section of the Applicant’s remarks, the Applicant argues that the claims have been amended to overcome the 35 U.S.C. 112(b) rejections of the previous office action. The Examiner agrees, and has thus withdrawn those rejections. However, the newly amended claims have raised a new 35 U.S.C. 112(b) rejection as detailed above.
Applicant’s arguments on pages 9-17 in the “Claim Rejections - 35 USC 103” section of the Applicant’s remarks with respect to the newly amended claims, particularly the addition of claiming a spherical dome, have been considered but are moot in view of new grounds of rejection with new additional Hickmann and Giulianotti references being used in the current rejections as discussed above.
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 JACQUELINE M PINDERSKI whose telephone number is (571)272-7032. The examiner can normally be reached Monday-Friday 7:00-4:00.
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/JACQUELINE M PINDERSKI/Examiner, Art Unit 3785
/RACHEL T SIPPEL/Primary Examiner, Art Unit 3785