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
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Objections
Claim 2 is objected to because of the following informalities:
In claim 2, line 2, the term “wherein , in” is suggested to be changed to --wherein, in-- in order to fix spacing error.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: the limitations “an atomization portion configured to atomize a liquid” (claim 1, lines 2-3, the term “portion” is a generic placeholder and the function is “configured to atomize a liquid”), “a positioning mechanism for positioning the first attachment portion with respect to the first opening portion” (claim 3, lines 3-4, the term “mechanism” is a generic placeholder and the function is “for positioning the first attachment portion with respect to the first opening portion”) and “a main body portion configured to control the atomization portion” (claim 10, line 3, the term “portion” is a generic placeholder and the function is “configured to control the atomization portion”).
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-10 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 pre-AIA the applicant regards as the invention.
Regarding claim 1, the limitation “a housing body that houses an atomization portion configured to atomize a liquid and includes a first opening portion and a second opening portion” (lines 2-3) is unclear as to which structure includes a first opening portion and a second opening portion, the housing body or the atomization portion. If it is the housing body, suggest to amend to --a housing body that houses an atomization portion configured to atomize a liquid and the housing body includes a first opening portion and a second opening portion--.
Regarding claim 1, the limitation “a mouthpiece in which a first attachment portion including a first check valve and configured to be attachable to and detachable from the first opening portion and a tubular second attachment portion including a second check valve and configured to be attachable to and detachable from the second opening portion are integrally configured” (lines 3-7) is unclear as to which structure is “configured to be attachable to and detachable from the first opening portion”, the mouthpiece, the first attachment portion or the first check valve. Furthermore, it is unclear as to which structure is “configured to be attachable to and detachable from the second opening portion”, the mouthpiece, the tubular second attachment portion, the second check valve or another structure mentioned before. Furthermore, the limitation “are integrally configured” is unclear as to which structures are being referred to by the limitation “are integrally configured”.
Any remaining claims are rejected for their dependency on a rejected base 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 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 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.
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.
Claims 1-3, 5, 7-8 and 10 are rejected under 35 U.S.C. 102(a)(1) as anticipated by Tseng (6,732,731) or, in the alternative, under 35 U.S.C. 103 as obvious over Tseng (6,732,731) in view of Berry (2009/0139888).
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Regarding claim 1, Tseng discloses a nebulizer kit (entire kit shown in fig. 1 minus 7/15, see col 2, line 31 to col 3, line 45) comprising: a housing body (body 1, 33, 31, see fig. 1) that houses an atomization portion (32 or 32 and 2, see fig. 1, see col 2, lines 56-67 and col 3, lines 1-24) configured to atomize a liquid and includes a first opening portion and a second opening portion (see the annotated-Tseng fig. 1 above); and a mouthpiece (4, figs. 1-5, see col 3, lines 25-35, Tseng discloses that the output section 42 is inserted into the mouth of the patient) in which a first attachment portion including a first check valve (411, see the annotated-Tseng fig. 3 above, col 3, lines 25-35) and configured to be attachable to and detachable from the first opening portion (see the annotated-Tseng figs. 1 and 3 above) and a tubular second attachment portion including a second check valve (421, figs. 1-3, col 3, lines 25-35, Tseng discloses that 411 is an air intake valve that opens to let air in to mix with the atomization while 421 is an air discharge valve that are used to discharge the exhaled air, and from the design of the valves as disclosed, the valves are check valves) and configured to be attachable to and detachable from the second opening portion are integrally configured (see the annotated-Tseng fig. 3 above and figs. 1-5, the mouthpiece having the portions and valves are integrally configured, furthermore, as shown, the mouthpiece comprising the first attachment portion is attachable and detachable from the first opening portion formed by 11 and alternatively, the mouthpiece is configured to be attachable and detachable from the alternative first opening portion indirectly through 3, furthermore, the mouthpiece comprising a tubular second attachment portion is also attachable and detachable from the second opening portion formed by 331, see figs. 1-5 and col 3, lines 25-35 and col 4, lines 4-8), wherein an inhalation attachment (6, fig. 1, col 4, lines 4-8) different from the mouthpiece is attachable to the second opening portion in a state in which the mouthpiece is removed from the housing body (figs. 1-5 and col 4, lines 4-8, the cap 6 is a protective cap that allows the user to inhale through the mouthpiece when the cap uncovers the mouthpiece, therefore, the cover 6 is an inhalation attachment, it is noted that the claim merely claims “an inhalation attachment” without defining specific structure(s) of the inhalation attachment, therefore, does not prevent the interpretation of the cap 6 being interpreted as an inhalation attachment, furthermore, both the cap and the mouthpiece 4 are detachable from the housing body, therefore, the cap 6 can be indirectly attachable to the second opening portion in a state in which the mouthpiece 4 is removed from the housing body, it is noted that throughout the claim, the “attachable” limitation is not being defined as a direct attachment, the term “attachable” can include direct attachment or indirect attachment, therefore, cap 6 being attached to body 1 would be attachable to second opening portion that is part of the body 1).
If there is any doubt that the cover 6 of Tseng can be considered as an inhalation attachment that is part of a kit. Berry teaches a kit having one or more spare mouthpieces, one mouthpiece is being interpreted as a mouthpiece and the spare mouthpiece can be interpreted as an inhalation attachment (see paragraphs 0013, 0030 and 0042).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to duplicate the mouthpiece of Tseng such that there are a plurality of spare mouthpieces as taught by Berry for the purpose of providing convenience to the user by allowing a spare mouthpieces to be used when one mouthpiece is dirty, broken or lost (see paragraphs 0013, 0030 and 0042 of Berry).
Regarding claim 2, Tseng or the modified Tseng discloses that in a state in which the mouthpiece is attached to the housing body, the first check valve (411 of Tseng) takes outside air into the housing body in accordance with an inhalation operation using the mouthpiece, and the second check valve (421 of Tseng) delivers exhaled air to outside of the second attachment portion in accordance with an exhalation operation using the mouthpiece (see figs. 1-3 and col 3, lines 25-35 of Tseng, Tseng discloses that the first check valve 411 is an air intake valve while the second check valve 421 is an air discharge valve).
Regarding claim 3, Tseng or the modified Tseng discloses that the first opening portion and the first attachment portion are provided with a positioning mechanism for positioning the first attachment portion with respect to the first opening portion (see the annotated-Tseng fig. 3 above with reference to fig. 4 of Tseng and col 4, lines 4-8 of Tseng).
Regarding claim 5, Tseng or the modified Tseng discloses that the mouthpiece is configured such that the inhalation attachment (cap 6 of Tseng or additional mouthpiece as modified by Berry) is not attachable to the second attachment portion (see figs. 1-5, cap 6 of Tseng is not directly attachable to the second attachment portion in that there is no specific connector or interface to make cap 6 and mouthpiece attachable to one another, alternatively, the cap 6 is removable, therefore, one can keep the cap 6 away from the second attachment portion such that they are not attachable, alternatively, under the modification with Berry, the additional mouthpiece is a duplicate of the mouthpiece of Tseng, therefore, they are not attachable to one another, see the annotated-Tseng fig. 3 above).
Regarding claim 7, Tseng or the modified Tseng discloses that the first opening portion is open in a longitudinal direction of the housing body and the second opening portion is open in a transverse direction of the housing body (see the annotated-Tseng fig. 1 above, the first opening portion and the second opening portion can be defined as an opening portions that are three dimensional portion comprising space or three dimensional space, which would extend in both the longitudinal direction and the transverse direction).
Regarding claim 8, Tseng or the modified Tseng discloses that the first opening portion is larger than the second opening portion (see the annotated-Tseng fig. 1 above).
Regarding claim 10, Tseng or the modified Tseng discloses a nebulizer comprising the nebulizer kit according to claim 1; a main body portion (7 and 15 of Tseng, col 2, lines 46-55, col 4, lines 9-11 of Tseng) configurated to control the atomization portion (32 or 32/2, see fig. 1, see col 2, line 31 to col 3, line 45 of Tseng); and the inhalation attachment (cap 6 of Tseng or additional/spare mouthpiece as modified by Berry).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Tseng (6,732,731) and alternatively in view of Berry (2009/0139888) as applied to claim 1 above, and further in view of Von Hollen (2014/0230811).
Regarding claim 4, Tseng or the modified Tseng discloses that the mouthpiece includes a connecting portion of the second check valve (421 of Tseng) and that connects the first attachment portion and the second attachment portion and the connecting portion is formed from a material (the stem portion of valve 421 is the connecting portion, as shown in the annotated-Tseng fig. 1 above, relatively, the stem portion of valve 421 is a connection portion that connects the first attachment portion and the second attachment portion, which would be formed of a material), but fails to disclose that the material of the connecting portion is elastically deformable.
However, Von Hollen discloses an exhaust flap valve that is elastically deformable (see elastic valve member 44 of exhaust valve 42 in paragraph 0035).
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 connecting member and the second valve of Tseng or the modified Tseng to be made of a material that is elastically deformable as taught by Von Hollen for the purpose of providing an alternative exhaust valve material that would allow the valve to open when the user is expiring (see paragraph 0035 of Von Hollen).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Tseng (6,732,731) in view of Berry (2009/0139888) as applied to claim 1 above.
Regarding claim 6, the modified Tseng discloses that an outer diameter of at least a part of a suction port end portion of the mouthpiece is larger than an inner diameter of an attachment portion of the inhalation attachment to the housing body (see the modification with Berry in the rejection to claim 1 above, after the modification with Berry, there are two mouthpieces, one mouthpiece is being interpreted as the mouthpiece and the duplicated mouthpiece is being interpreted as the inhalation attachment, therefore, the outer diameter of the suction port end portion of the mouthpiece is larger than an inner diameter of an attachment portion of the inhalation attachment (diameter of portion forming passage 331 of duplicated mouthpiece), see the annotated-Tseng figs. 1 and 3 above).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Tseng (6,732,731) and alternatively in view of Berry (2009/0139888) as applied to claim 1 above, and further in view of Stapleton (2002/0056448).
Regarding claim 9, Tseng or the modified Tseng discloses that a movable portion of the second check valve is provided eccentrically to a suction port end portion side of the mouthpiece (see the valve stem of 421, there would be a movable portion of the valve that moves when the user exhaled due to the way the valve is being arranged, furthermore, the location of the movable portion would be provided eccentrically to a suction port end portion side of the mouthpiece since the center of the suction port end portion side can be defined such that the suction port end portion side does not include where the movable portion is being positioned, see the annotated-Tseng fig. 1 above and col 3, lines 25-35 of Tseng), but fails to disclose that the valve has a fulcrum.
However, Stapleton teaches a check valve comprising a movable part that moves relative to a fulcrum (see valve 3 and 4, fig. 1, paragraphs 0023-0025, Stapleton discloses that when the user exhales the valve 3 is raised so that orifice 2 is opened, and from the design, when valve 3 is raised, there would be a fulcrum due to 4 being constrained to the mouthpiece).
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 second valve of Tseng or the modified Tseng to have the check valve as taught by Stapleton for the purpose of providing an alternative valve that would provide the predictable result of allowing exhaled air to escape and preventing air from the outside to enter through the second check valve (see paragraphs 0023-0025 of Stapleton).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Tseng (6,732,731) and alternatively in view of Berry (2009/0139888) as applied to claim 1 above, and further in view of Johnson (2002/0121275).
Regarding claim 9, Tseng or the modified Tseng discloses that a movable portion of the second check valve is provided eccentrically to a suction port end portion side of the mouthpiece (see the valve stem of 421, there would be a movable portion of the valve that moves when the user exhaled due to the way the valve is being arranged, furthermore, the location of the movable portion would be provided eccentrically to a suction port end portion side of the mouthpiece since the center of the suction port end portion side can be defined such that the suction port end portion side does not include where the movable portion is being positioned, see the annotated-Tseng fig. 1 above and col 3, lines 25-35), but fails to disclose that the valve has a fulcrum.
However, Johnson teaches a check valve comprising a movable part that moves relative to a fulcrum (see valve 38 having a movable part that pivots relative to end that is fixed by 50, figs. 7-9 and paragraphs 0036 and 0040).
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 second valve of Tseng or the modified Tseng to have the check valve as taught by Johnson for the purpose of providing an alternative valve that would provide the predictable result of allowing exhaled air to escape and preventing air from the outside to enter through the second check valve (see paragraphs 0036 and 0040 of Johnson).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Gallem (GB 2358356) is cited to show a mouthpiece comprising a first check valve and a second check valve.
Brugger (EP 0626180) is cited to show a mouthpiece comprising a flap valve that pivots.
Brugger (EP 0281650) is cited to show a nebulizer comprising a mouthpiece having a one-way valve and an inlet portion comprising a one-way valve.
Gramann (2016/0375206) is cited to show a mouthpiece for an inhaler, the mouthpiece comprising an exhalation valve.
Alizoti (2018/0008789) is cited to show a nebulizer comprising a mouthpiece and an assembly comprising a valve.
Tsai (2019/0076605) is cited to show a nebulizer.
Abate (2012/0227735) is cited to show a nebulizer comprising an opening configured to be attached to a mask or a mouthpiece.
Tseng (2006/0137682) is cited to show a nebulizer comprising a mouthpiece having a valve.
Knoch (6,962,151) is cited to show an inhalation nebulizer comprising a mouthpiece having a flap valve.
Hebrank (2021/0106772) is cited to show an inhalation nebulizer comprising a mouthpiece having a flap valve.
Schulz (2013/0239956) is cited to show an inhalation nebulizer comprising a mouthpiece having a flap valve.
Puderbaugh (6,026,807) is cited to show a mouthpiece comprising a valve and a cap connected by an connecting member.
Engelbreth (10,709,852) is cited to show a nebulizer kit.
Salter (6,176,234) (5,584,285) is cited to show a mouthpiece for a nebulizer.
Fugelsang (2002/0157664) is cited to show an inhaler having a valve.
Shargian (11,779,714) is cited to show a mouthpiece comprising a deformable connecting member.
Tanaka (2003/0062038) is cited to show a nebulizer comprising an attachment portion configured to be attached to a mouthpiece or a mask.
Gramann (2017/0340846) is cited to show a mouthpiece comprising a valve.
Johnson (7,204,245) is cited to show a mouthpiece comprising an intake valve and an outtake valve.
Spallek (2009/0314287) is cited to show an inhalation attachment comprising a plurality of valves.
Faram (10,258,758) is cited to show a nebulizer comprising an attachment comprising a one way valve.
Clementi (5,875,774) is cited to show a mouthpiece comprising a first check valve and a second check valve.
Foley (6,994,083) is cited to show a nebulizer comprising an upper portion comprising a valve mechanism.
Hamaguchi (2008/0083409) is cited to show an inhaler comprising a mouthpiece having a check valve.
Reed (2017/0049976) is cited to show an outlet portion being connected to a body via a connecting member.
Sladek (6,039,042) is cited to show an inhaler comprising a mouthpiece having a first check valve and a second check valve.
Niebling (2020/0288786) is cited to show a kit comprising a plurality of mouthpieces.
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/TU A VO/Primary Examiner, Art Unit 3785