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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “outlet” (including “first outlet” and “second outlet” of claim 78) must be shown or the feature(s) canceled from the claim(s). While the specification discloses “an inlet” and “an exhaust port 98”, it is unclear if the latter is intended to be construed as the “outlet” or not. No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: as noted above, the specification lack proper antecedent basis for the claimed “outlet(s)”.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 77-80 and 83-94 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
At line 2 of claim 77, it is unclear if “the cavity” refers to “a cavity”; “an upper nasal cavity”; or “a lower oral cavity” of claim 76. It appears that “the cavity” in claim 77 should likely read --the oral cavity-- in accordance with 9 of claim 76.
Claim 78 recites the “mask of claim 76 wherein the outlet comprises a first outlet, and further comprising a second outlet…”. It is unclear if the mask or the outlet further comprises a second outlet. For purposes of examination, it will be construed as the mask further comprising a second outlet.
Claim 80 recites the “mask of claim 79 wherein the one-way exhaust valve comprises a first one-way exhaust valve, and further comprising a second one-way exhaust valve …”. It is unclear if the mask or the first one-way exhaust valve further comprises a second one-way exhaust valve. For purposes of examination, it will be construed as the mask further comprising a second one-way exhaust valve.
Claims 83, 91 and 92 are indefinite as they depend from cancelled claim 75. However, for purposes of examination, each claim will be construed as dependent upon independent claim 76.
Claim 87 recites the “mask of claim 86 wherein the receptacle defines a receptacle cavity, wherein the orifice comprises a first orifice communicating between the receptacle cavity and the nasal cavity, and further comprising a second orifice…”. It is unclear if the mask; the receptable; or the orifice further comprises a second orifice.
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 76, 78, 81-84 and 91-93 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sher et al. (U.S. Pub. No. 2009/0159084). Regarding claim 76, Sher et al. (hereinafter Sher) teaches a mask comprising:
a body 502/508 (Figs. 2A-2B and [0042]-[0043]) comprising:
an interior surface defining a cavity (Fig. 2B);
a barrier 528 separating the cavity into an upper nasal cavity 524 shaped to receive a user's nose and a lower oral cavity 526 adapted to be in communication with the user's mouth (Fig. 2B and [0043]);
an exterior surface exposed to an ambient environment (Figs. 2A-2B);
an inlet in fluid communication with the nasal cavity (an inlet is formed in the body to enable fluid communication between 524 and channel 532 – as shown in Fig. 2B and disclosed at [0052]; and [0041]: “port 504 can be divided”); and
an outlet in fluid communication between the oral cavity and the ambient environment ([0041]: “port 504 can be divided” which provides both an “inlet” and an “outlet” as claimed; additionally “expiration holes 544 can be defined through mask shell 502 for one or both of breathing chambers 524, 526 to allow a user to exhale waste gas from one or both of chambers 524, 526” [0044]).
Regarding claim 78, the outlet comprises a first outlet, and the mask further comprises a second outlet in fluid communication between the nasal cavity and the ambient environment (“expiration holes 544 can be defined through mask shell 502 for one or both of breathing chambers 524, 526 to allow a user to exhale waste gas from one or both of chambers 524, 526” [0044]).
Regarding claim 81, the barrier comprises an interface edge configured to engage an upper lip of the user (see downturned portion of barrier 528 in Fig. 2B; and [0023]).
Regarding claim 82, the body is free of any outlet in communication between the nasal cavity and the ambient environment (““expiration holes 544 can be defined through mask shell 502 for one…of breathing chambers 524, 526 to allow a user to exhale waste gas from one…of chambers 524, 526” [0044]).
Regarding claim 83, the mask further comprises a therapeutic substance dispenser (“flow generator”) in fluid communication with the nasal cavity ([0009] and [0047]).
Regarding claim 84, the therapeutic substance dispenser is spaced apart from the inlet by gas supply tube 506 (Figs. 2A-2B and [0047]).
Regarding claim 91, the inlet is in fluid communication with only the upper nasal cavity (an inlet is formed in the body to enable fluid communication between 524 and channel 532 – as shown in Fig. 2B and disclosed at [0052]; and [0041]: “port 504 can be divided”; therefore channel 532 is only in fluid communication with the upper nasal cavity – [0048]).
Regarding claim 92, Sher teaches a medicament delivery assembly comprising the mask of claim 76 and a medicament delivery device 506 coupled to the inlet ([0047]-[0048] and Figs. 2A-2B).
Regarding claim 93, the medicament delivery device comprises a holding chamber (channel 532) (Fig. 2B and [0048]).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 77, 79 and 80 are rejected under 35 U.S.C. 103 as being unpatentable over Sher et al. (U.S. Pub. No. 2009/0159084) in view of Lehman (U.S. Patent No. 8,960,195). Regarding claim 77, while Sher teaches that the mask further comprises an exhaust outlet in fluid communication between the cavity and the ambient environment [0044], Sher fails to disclose explicitly that a one-way exhaust valve is disposed in the outlet. Lehman teaches a mask interface for inhalation of breathing therapy to a patient (see Abstract), wherein a one-way valve is disposed in an exhaust port for allowing the expiration of gases from the patient (col. 5, lines 36-42). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to configure an exhaust outlet as taught by Sher, to include a one-way valve as suggested by Lehman, as Sher recognizes the inclusion of an exhaust outlet/port/holes to allow the exhalation of waste gas from the chambers of the mask [0044], and Lehman teaches that an exhaust outlet/port may comprise perforations/holes (as also taught by Sher), and further that a one-way valve would likewise allow free-flow of expired gases (col. 5, lines 36-42).
Regarding claim 79, while Sher teaches that the mask further comprises a second exhaust outlet in fluid communication between the nasal cavity and the ambient environment [0044], Sher fails to disclose explicitly that a one-way exhaust valve is disposed in the second outlet. Lehman teaches a mask interface for inhalation of breathing therapy to a patient (see Abstract), wherein a one-way valve is disposed in an exhaust port for allowing the expiration of gases from the patient (col. 5, lines 36-42). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to configure an exhaust outlet as taught by Sher, to include a one-way valve as suggested by Lehman, as Sher recognizes the inclusion of an exhaust outlet/port/holes to allow the exhalation of waste gas from the chambers of the mask [0044], and Lehman teaches that an exhaust outlet/port may comprise perforations/holes (as also taught by Sher), and further that a one-way valve would likewise allow free-flow of expired gases (col. 5, lines 36-42).
Regarding claim 80, while Sher teaches that the mask further comprises a second exhaust outlet in fluid communication between the nasal cavity and the ambient environment (“expiration holes 544 can be defined through mask shell 502 for one or both of breathing chambers 524, 526 to allow a user to exhale waste gas from one or both of chambers 524, 526” [0044]), Sher fails to disclose explicitly that a second one-way exhaust valve is disposed in the first outlet. Lehman teaches a mask interface for inhalation of breathing therapy to a patient (see Abstract), wherein a one-way valve is disposed in an exhaust port for allowing the expiration of gases from the patient (col. 5, lines 36-42). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to configure a second exhaust outlet as taught by Sher, to include a one-way valve as suggested by Lehman, as Sher recognizes the inclusion of a second exhaust outlet/port (or set of perforations) to allow the exhalation of waste gas from both chambers of the mask [0044], and Lehman teaches that an exhaust outlet/port may comprise perforations/holes (as also taught by Sher), and further that a one-way valve would likewise allow free-flow of expired gases (col. 5, lines 36-42).
Claims 85-89 and 94 are rejected under 35 U.S.C. 103 as being unpatentable over Sher et al. (U.S. Pub. No. 2009/0159084) in view of O’Callaghan et al. (U.S. Pub. No. 2019/0160237). Regarding claim 85, while Sher teaches that the therapeutic substance dispenser (“flow generator”) is in fluid communication with the nasal cavity ([0051]-[0052]), Sher fails to disclose explicitly that the therapeutic substance dispenser comprises a receptacle in fluid communication with the nasal cavity. O’Callaghan et al. (hereinafter O’Callaghan) teaches a device for administering inhaled therapy to a patient via a pressurized source (see Abstract and [0016]), as likewise disclosed by Sher, wherein the pressurized source is a pressurized metered dose inhaler ([0016] and [0023]) comprising a receptacle 110 in fluid communication with a nasal cavity (Fig. 1A and [0018]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to configure the pressurized source of treatment as taught by Sher, to comprise a receptacle in fluid communication with the nasal cavity as suggested by O’Callaghan, as Sher recognizes the provision of breathable gas at different pressures to a nasal breathing chamber [0052], wherein various types of flow generators may be used with the disclosed device [0047] and O’Callaghan teaches that a receptacle/cartridge enables replacement/refill when the drug is running out [0046], and that different pressurized gas sources for breathing therapy are commonly in the form of atomizers, nebulizers, pressurized metered dose inhalers and medical aerosol generators ([0016]-[0017]).
Regarding claim 86, O’Callaghan teaches wherein the receptacle comprises an orifice communicating between the receptacle and a nasal cavity ([0018]-[0019] and Fig. 1A).
Regarding claim 87, and in view of its indefinite nature, Sher teaches a “second orifice” 544 communicating between the nasal cavity and the ambient environment [0044], however Sher fails to disclose wherein the receptacle defines a receptacle cavity, wherein the orifice comprises a first orifice communicating between the receptacle cavity and the nasal cavity. O’Callaghan teaches wherein the receptacle 110 defines a receptacle cavity (where cartridge 112 is placed) (Fig. 1A and [0018]), wherein the orifice comprises a first orifice communicating between the receptacle cavity and the nasal cavity ([0018]-[0019] and Fig. 1A). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to configure the pressurized source of treatment as taught by Sher, to comprise a receptacle defining a receptacle cavity in fluid communication with the nasal cavity as suggested by O’Callaghan, as Sher recognizes the provision of breathable gas at different pressures to a nasal breathing chamber [0052], wherein various types of flow generators may be used with the disclosed device [0047] and O’Callaghan teaches that a receptacle/cartridge with a cavity enables replacement/refill when the drug is running out [0046], and that different pressurized gas sources for breathing therapy are commonly in the form of atomizers, nebulizers, pressurized metered dose inhalers and medical aerosol generators ([0016]-[0017]).
Regarding claims 88 and 89, while Sher teaches that the mask further comprises a therapeutic substance dispenser (“flow generator”), Sher fails to disclose explicitly a therapeutic component disposed in the therapeutic substance dispenser, wherein the therapeutic component comprises a liquid. O’Callaghan teaches a device for administering inhaled therapy to a patient via a pressurized source (see Abstract and [0016]), as likewise disclosed by Sher, wherein the pressurized source is a nebulizer ([0016] and [0041]; nebulizers containing a liquid that is converted into a fine mist for inhalation). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to configure the pressurized, metered source as taught by Sher, to be a nebulizer as suggested by O’Callaghan, as Sher recognizes the provision of breathable gas at different pressures to the nasal breathing chamber [0052] and O’Callaghan teaches that pressurized gas sources for breathing therapy are commonly in the form of atomizers, nebulizers, pressurized metered dose inhalers and medical aerosol generators ([0016]-[0017]).
Regarding claim 94, while Sher teaches the medicament delivery device comprises a holding chamber (channel 532) (Fig. 2B and [0048]), wherein a source of pressurized gas is coupled to the holding chamber ([0047]-[0048] and [0051]-[0052]), Sher fails to disclose explicitly that the source of pressurized gas coupled to the holding chamber is a pressurized metered dose inhaler. O’Callaghan et al. (hereinafter O’Callaghan) teaches a device for administering inhaled therapy to a patient via a pressurized source (see Abstract and [0016]), as likewise disclosed by Sher, wherein the pressurized source is a pressurized metered dose inhaler ([0016] and [0023]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to configure the pressurized, metered source as taught by Sher, to be a pressurized metered dose inhaler as suggested by O’Callaghan, as Sher recognizes the provision of breathable gas at different pressures to the nasal breathing chamber [0052] and O’Callaghan teaches that pressurized gas sources for breathing therapy are commonly in the form of atomizers, nebulizers, pressurized metered dose inhalers and medical aerosol generators ([0016]-[0017]).
Claim 90 is rejected under 35 U.S.C. 103 as being unpatentable over Sher et al. (U.S. Pub. No. 2009/0159084) in view of O’Callaghan et al. (U.S. Pub. No. 2019/0160237) and further in view of Samson et al. (U.S. Pub. No. 2016/0325058). Regarding claim 90, while Sher and O’Callaghan teaches a variety of therapeutic components (see O’Callaghan [0016]-[0017]), the combination fails to disclose explicitly that the therapeutic component comprises an inhaler stick. Samson et al. (hereinafter Samson) teaches a pulmonary medication dosing device (PMDD) [0005], wherein the PMDD may be configured to deliver various substances for inhalation by the patient in various forms ([0055]-[0056]) as likewise disclosed by Sher and O’Callaghan, wherein the PMDD may deliver a substance to the patient that is in the form of a stick, a spray or a powder, for instance [0058]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to configure a therapeutic component as taught by Sher and O’Callaghan, to be in various forms for inhalation such as a stick, spray or powder, as taught by Samson, as Sher and O’Callaghan recognize the delivery of inhaled breathing treatments in various forms, and Samson teaches that the PMDD may deliver the therapeutic substance to the patient from various sources such as a powder, suspension, stick or a spray [0058].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINE HOPKINS MATTHEWS whose telephone number is (571)272-9058. The examiner can normally be reached Monday - Friday, 7:30 am - 4:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles A Marmor, II can be reached at (571) 272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHRISTINE H MATTHEWS/Primary Examiner, Art Unit 3791
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