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 .
Priority
Acknowledgement is made to Applicant’s claim to priority U.S. Provisional App. No. 63/461,093 filed April 21, 2023.
Status of Claims
Claims 1-32, filed April 19, 2024, are presently pending in this application.
Claim Objections
Claim 14 is objected to because of the following informalities:
Claim 14 recites “114”, ln 1 should read --14--.
Appropriate correction is required.
Double Patenting
Applicant is advised that should claim 17 be found allowable, claim 32 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 706.03(k).
Examiner believes claim 32 contains a typographical error and should depend from claim 18.
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 31 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 31 recites the limitation "the inlet" in ln 2. There is insufficient antecedent basis for this limitation in the claim.
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) 1-3, 8, 14-15, 18-19, 24, and 28-30 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Alizoti et al. (U.S. Pub. No. 2017/0333645; hereinafter: “Alizoti”).
Regarding Claim 1, Alizoti discloses a valved holding chamber assembly comprising: a holding chamber (2; Fig. 3, 4, 9) adapted to contain a substance (¶¶ 0102-0104) and comprising an input end (at 8; Fig. 3, 4, 9) adapted to receive a pressurized metered dose inhaler (24; Fig. 3, 4, 9) and an output end (at 12; Fig. 3, 4, 9); an inhalation valve (16; Fig. 3, 4, 9) disposed at the output end of the holding chamber (Fig. 3, 4, 9) and moveable to an open position in response to an inhalation flow through the holding chamber (Fig. 9; ¶ 0102); a user interface (12; Fig. 3, 4, 9) coupled to the output end of the holding chamber in flow communication with the holding chamber when the inhalation valve is in the open position (Fig. 3, 4, 9; ¶ 0102), wherein the inhalation valve defines a first inhalation flow path (A, Fig. A annotated below) between the input end and the user interface; a flow channel (34’, 58; Fig. 9) comprising an inlet (36; Fig. 9) in flow communication with the holding chamber between the input end and the output end and an outlet (38; Fig. 9) in flow communication with the user interface downstream of the inhalation valve (¶¶ 0103, 0118), wherein the flow channel bypasses the inhalation valve (¶¶ 0103, 0118), and wherein the flow channel defines a second inhalation flow path (B, Fig. A annotated below) between the input end and the user interface (Fig. 9); and a flow indicator (34’; Fig. 9) positioned in the flow channel (¶¶ 0118-0119), wherein the flow indicator is actuatable in response to a flow rate in the flow channel during inhalation (¶¶ 0118-0119).
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Figure A, Adapted from Figure 9 of Alizoti.
Regarding Claim 2, Alizoti discloses the valved holding chamber assembly wherein the flow indicator comprises a whistle (¶¶ 0119, 0271; Fig. 112; 51c).
Regarding Claim 3, Alizoti discloses the valved holding chamber assembly wherein the flow indicator is actuatable when the flow rate in the channel is greater than a threshold flow rate [¶¶ 0118-0119, 0125; Examiner notes: Alizoti discloses the low indicator (flow sensor 34’) configured to detect certain flow rates.].
Regarding Claim 8, Alizoti discloses the valved holding chamber assembly wherein the inhalation valve comprises a first flow resistance (¶ 0102; resistance created by duckbill valve) and the flow indicator comprises a second flow resistance, wherein the second flow resistance is greater than the first flow resistance (¶¶ 0142, 0143; Fig. 51c, tighter flow path in bypass creates greater flow resistance in the second flow path).
Regarding Claim 14, Alizoti discloses the valved holding chamber assembly wherein the input end is configured to receive a mouthpiece portion (C, Fig. A annotated above) of a pressurized metered dose inhaler (24; Fig. 9; ¶ 0102).
Regarding Claim 15, Alizoti discloses the valved holding chamber assembly further comprising an exhalation valve (18; Fig. 3) disposed in the second inhalation flow path (¶ 0102).
Regarding Claim 18, Alizoti discloses a valved holding chamber assembly comprising: a first flow path (A, Fig. A annotated above) between an input end (at 8; Fig. 3, 4, 9) and a user interface (12; Fig. 3, 4, 9), wherein the input end is configured for coupling to a medicament delivery device (24; Fig. 9; ¶ 0102), wherein the first flow path comprises an inhalation valve (16; Fig. 3, 4, 9) having a first flow resistance (¶ 0102; resistance created by duckbill valve); and a second flow path (B, Fig. A annotated above) between the input end and the user interface (Fig. 9), wherein the second flow path bypasses the inhalation valve (¶¶ 0103, 0118), wherein the second flow path comprises a flow indicator (34’; Fig. 9) having a second flow resistance, wherein the second flow resistance is greater than the first flow resistance (¶¶ 0142, 0143; Fig. 51c, tighter flow path in bypass creates greater flow resistance in the second flow path).
Regarding Claim 19, Alizoti discloses the valved holding chamber assembly wherein the flow indicator comprises a whistle (¶¶ 0119, 0271; Fig. 112; 51c).
Regarding Claim 24, Alizoti discloses the valved holding chamber assembly wherein the flow indicator is actuatable when a flow rate in the second flow path exceeds a first threshold flow rate (¶¶ 0118-0119, 0125).
Regarding Claim 28, Alizoti discloses the valved holding chamber assembly wherein the user interface comprises a mouthpiece (12 act as a mouthpiece; Fig. 9; ¶ 0102).
Regarding Claim 29, Alizoti discloses the valved holding chamber assembly wherein the input end is configured to receive a mouthpiece portion (C, Fig. A annotated above) of a pressurized metered dose inhaler (24; Fig. 9; ¶ 0102).
Regarding Claim 30, Alizoti discloses the valved holding chamber assembly further comprising an exhalation valve (18; Fig. 3) disposed in the second inhalation flow path (¶ 0102).
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.
Claim(s) 4-5 and 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Alizoti in view of Von Hollen et al. (U.S. Pub. No. 2011/0232636; hereinafter: “Von Hollen”).
Regarding Claims 4 and 20, Alizoti discloses the valved holding chamber assembly of claims 1 and 18, shown above.
Alizoti does not specifically disclose the valved holding chamber assembly further comprising an acoustical opening communicating between the chamber housing and the ambient environment proximate the whistle.
Von Hollen teaches a chamber comprising an acoustical opening (80; Fig. 18-23) communicating between a chamber housing (2; Fig. 16, 17) and the ambient environment proximate a whistle (80; Fig. 20-23; ¶ 0060) for the purpose of allowing for effective operability and optimization of sound intensity of the whistle (¶ 0060).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the valved holding chamber assembly of Von Hollen to include the acoustical opening communicating between the chamber housing and the ambient environment proximate the whistle as taught by Von Hollen for the purpose of allowing for effective operability and optimization of sound intensity of the whistle (See Von Hollen: ¶ 0060).
Regarding Claims 5 and 21, the modified device of Alizoti discloses the valved holding chamber assembly wherein further comprising a one-way valve (See Von Hollen: 130; Fig. 44, 45) communicating with the acoustical opening (See Von Hollen: ¶ 0065).
Claim(s) 6 is rejected under 35 U.S.C. 103 as being unpatentable over Alizoti in view of Newhouse et al. (U.S. Pub. No. 2012/0318261; hereinafter: “Newhouse”).
Regarding Claim 6, Alizoti discloses the valved holding chamber assembly of claim 2, shown above.
Alizoti does not specifically disclose the valved holding chamber assembly wherein the whistle comprises first and second whistle emitting first and second tones, wherein the first tone varies from the second tone by at least one semi-tone.
Newhouse teaches a chamber assembly comprising a whilst (40; Fig. 1A, 1B) having first and second whistle emitting first and second tones(¶¶ 0033, 0034; Claims 6-8), wherein the first tone varies from the second tone by at least one semi-tone (¶¶ 0033, 0034; Claims 6-8; Examiner notes: Newhouse discloses different whistles with different flow rates required to produce a sound.) for the purpose of informing the user to change their inhalation effort to obtain an optimal inhalation velocity (¶ 0033).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the valved holding chamber assembly of Alizoti to include the whistle comprising the first and the second whistle emitting first and second tones, wherein the first tone varies from the second tone by at least one semi-tone as taught by Newhouse for the purpose of informing the user to change their inhalation effort to obtain an optimal inhalation velocity (See Newhouse: ¶ 0033).
Claim(s) 7 is rejected under 35 U.S.C. 103 as being unpatentable over Alizoti in view of Newhouse as applied to claim 6 above, and further in view of Conlon et al. (U.S. Pub. No. 2019/0366018; hereinafter: “Conlon”).
Regarding Claim 7, the modified device of Alizoti discloses the valved holding chamber assembly, shown above.
The modified device of Alizoti does not specifically disclose the valved holding chamber assembly wherein the first and second whistles comprise first and second reeds respectively.
Conlon teaches a valved spacer comprising a flow indicator (70; Fig. 1-3, 22-23, 45) comprising a reed whistle (¶¶ 0089, 0107) for the purpose of generating a whistle sound that can be readily heard by the user indicating that the inhalation flow rate (¶¶ 0089, 0107).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the modified device of Alizoti to include the first and second whistles comprise first and second reeds respectively as taught by Conlon for the purpose of generating a whistle sound that can be readily heard by the user indicating that the inhalation flow rate (See Conlon: ¶¶ 0089, 0107).
Claim(s) 16-17 and 31-32 are rejected under 35 U.S.C. 103 as being unpatentable over Alizoti in view of Conlon.
Regarding Claims 16 and 31, Alizoti discloses the valved holding chamber assembly of claims 1 and 18, shown above.
Alizoti does not specifically disclose the valved holding chamber assembly further comprising a filter disposed in the inlet.
Conlon teaches a valved spacer comprising a flow indicator (170; Fig. 43-45) comprising a filter (173; Fig. 44; Examiner notes: Conlon discloses the filter as a reed that will provides a physical block and filters the flow of air to vibrate when air passes too fast from the inlet end.) disposed in an inlet (168; Fig. 42, 44) for the purpose of producing an audible signal when air passes too fast from the inlet end of the flow indicator (¶ 0107).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the valved holding chamber assembly of Alizoti to include the filter disposed in the inlet as taught by Conlon for the purpose of producing an audible signal when air passes too fast from the inlet end of the flow indicator (See Conlon: ¶ 0107).
Regarding Claims 17 and 32, Alizoti discloses the valved holding chamber assembly of claim 1, shown above.
Alizoti does not specifically disclose the valved holding chamber assembly further comprising a baffle disposed in the inlet.
Conlon teaches a valved spacer comprising a flow indicator (170; Fig. 43-45) comprising a baffle (173; Fig. 44) disposed in an inlet (168; Fig. 42, 44) for the purpose of providing a baffle configured to vibrate when air passes too fast from the inlet end of the flow indicator (¶ 0107).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the valved holding chamber assembly of Conlon to include the baffle disposed in the inlet as taught by Conlon for the purpose of providing a baffle configured to vibrate when air passes too fast from the inlet end of the flow indicator (See Conlon: ¶ 0107).
Claim(s) 22 is rejected under 35 U.S.C. 103 as being unpatentable over Alizoti in view of Von Hollen as applied to claim 20 above, and further in view of Newhouse.
Regarding Claim 22, the modified device of Alizoti discloses the valved holding chamber assembly of claim 20, shown above.
The modified device of Alizoti does not specifically disclose the valved holding chamber assembly wherein the whistle comprises first and second whistle emitting first and second tones, wherein the first tone varies from the second tone by at least one semi-tone.
Newhouse teaches a chamber assembly comprising a whilst (40; Fig. 1A, 1B) having first and second whistle emitting first and second tones(¶¶ 0033, 0034; Claims 6-8), wherein the first tone varies from the second tone by at least one semi-tone (¶¶ 0033, 0034; Claims 6-8; Examiner notes: Newhouse discloses different whistles with different flow rates required to produce a sound.) for the purpose of informing the user to change their inhalation effort to obtain an optimal inhalation velocity (¶ 0033).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify t the modified device of Alizoti to include the whistle comprising the first and the second whistle emitting first and second tones, wherein the first tone varies from the second tone by at least one semi-tone as taught by Newhouse for the purpose of informing the user to change their inhalation effort to obtain an optimal inhalation velocity (See Newhouse: ¶ 0033).
Claim(s) 23 is rejected under 35 U.S.C. 103 as being unpatentable over Alizoti in view of Von Hollen in view of Newhouse as applied to claim 22 above, and further in view of Conlon et al. (U.S. Pub. No. 2019/0366018; hereinafter: “Conlon”).
Regarding Claim 23, the modified device of Alizoti discloses the valved holding chamber assembly, shown above.
The modified device of Alizoti does not specifically disclose the valved holding chamber assembly wherein the first and second whistles comprise first and second reeds respectively.
Conlon teaches a valved spacer comprising a flow indicator (70; Fig. 1-3, 22-23, 45) comprising a reed whistle (¶¶ 0089, 0107) for the purpose of generating a whistle sound that can be readily heard by the user indicating that the inhalation flow rate (¶¶ 0089, 0107).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the modified device of Alizoti to include the first and second whistles comprise first and second reeds respectively as taught by Conlon for the purpose of generating a whistle sound that can be readily heard by the user indicating that the inhalation flow rate (See Conlon: ¶¶ 0089, 0107).
Allowable Subject Matter
Claims 9 and 25, and 10-13 and 26-27 by dependency, 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: Prior art of Alizoti, Von Hollen, Newhouse, and Conlon alone or in combination fail to disclose or render obvious the valved holding chamber assembly:
“wherein the flow channel comprises a first flow channel, the inlet comprises a first inlet, the outlet comprises a first outlet, the flow rate comprises a first flow rate, and the flow indicator comprises a first flow indicator, and further comprising a second flow channel comprising a second inlet in flow communication with the holding chamber between the input end and output end and a second outlet in flow communication with the user interface downstream of the inhalation valve, wherein the second flow channel defines a third inhalation flow path between the input end and the user interface separate from the first and second inhalation flow paths, and further comprising a second flow indicator positioned in the second flow channel, wherein the second flow indicator is actuatable in response to a second flow rate in the second flow channel during inhalation”, as recited in dependent claim 9.
“wherein the flow indicator comprises a first flow indicator, and further comprising a third flow path between the input end and the user interface, wherein the third flow path is separate from the first and second flow paths, wherein the third flow path comprises a second flow indicator having a third flow resistance, wherein the first flow resistance is greater than the third flow resistance”, as recited in dependent claim 25
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELLIOT S RUDDIE whose telephone number is (571)272-7634. The examiner can normally be reached M-F usually 9-7 EST.
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/ELLIOT S RUDDIE/Primary Patent Examiner, Art Unit 3785
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