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 .
Claim Objections
Claims 16 and 28 are objected to because of the following informalities:
Claim 16, line 1, “claim 15” should read “claim 15,”
Claim 28, line 1, it is recommended to change “a method for preparing the nebulization cup according to claim 15” to “a method for preparing the nebulization cup of claim 15”
Claim 28, line 2, “wherein by comprising” should read “comprising”
Appropriate correction is required.
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 21 and 25 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.
Claim 21 recites the limitation "the content of antistatic agent added to the cup lid" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. A content of antistatic agent added to the cup lid is introduced in claim 20. For purposes of examination, claim 21 is interpreted as being dependent from claim 20.
Claim 25 recites the limitation "the amphoteric antistatic agent" in lines 3-4. There is insufficient antecedent basis for this limitation in the claim. It is recommended to either add “an amphoteric antistatic agent” to claim 23 or change “the amphoteric antistatic agent” in claim 25 to “an amphoteric antistatic agent”.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 15, 18, 19, 28, and 29 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Steelman (US 20130276781).
Regarding claim 15, Steelman discloses
a nebulization cup (figs. 1-12; inhalation device or spacer 100; [0058]),
comprises a cup body and a cup lid (figs. 1-12; head 110; [0064] and [0065]),
a material of the cup body is transparent plastic (figs. 1-12; the sleeve member 180 is formed of a flexible plastic tube, [0080]-[0082]; see figs. 1-3, 8, and 10a which show the sleeve member being transparent), and
an antistatic agent is added to the cup body (figs. 1-12; the sleeve member 180 is formed of a material which can include an antistatic component; [0080]-[0082]).
Regarding claim 18, Steelman further discloses
the nebulization cup (inhalation device/spacer 100) according to claim 15,
wherein the material of the cup body is selected from a group consisting of polypropylene (PP), polylactic acid (PLA), polyethylene (PE) (figs. 1-12; the sleeve member 180 is formed of material such as low density polyethylene; [0081] and [0082]), polyvinyl chloride (PVC), polystyrene (PS) and polycarbonate (PC).
Regarding claim 19, Steelman further discloses
the nebulization cup (inhalation device/spacer 100) according to claim 15,
wherein a material of the cup lid is plastic (figs. 1-12; the head 110 can be formed of any suitable material such as high density polyethylene or polypropylene (types of plastics); [0083]), the plastic is selected from a group consisting of polypropylene (PP), polylactic acid (PLA), polyethylene (PE) (figs. 1-12; the head 110 is formed of high density polyethylene; [0083]), polyvinyl chloride (PVC), polystyrene (PS) and polycarbonate (PC).
Regarding claim 28, Steelman further discloses
a method for preparing (method of loading, blended, mixed or coating material of the cup body; [0081]) the nebulization cup (see claim 15, inhalation device 100) according to claim 15,
wherein by comprising a step of adding an antistatic agent component or an antistatic masterbatch to a raw material for preparing the cup body (figs. 1-12; the sleeve member 180 is formed of LDPE which is loaded, blended, mixed or coated with a supplemental material that enhances the anti-static properties of the LDPE; [0081] in other words an antistatic component is added to LDPE which is formed into the cup body).
Regarding claim 29, Steelman further discloses
a method for preventing and/or treating respiratory disease (method of using an inhalation device to convert medications for treatment of tracheal, bronchial, nasal and pulmonary conditions from a concentrated pressurized aerosol form into a nonpressurized, air diluted form for ease and greater efficacy of inhalation by a patient suffering from such a condition; [0057]),
comprising administrating drug by the nebulization cup (figs. 1-12; the dispenser 15 can be actuated to inject a prescribed or predetermined metered dose D of the medication into a chamber 102 defined by the inhalation device 100, where the medication dose is mixed with air in the chamber 102 to form a dispersed, gaseous medicine mixture M. A patient P can then inhale the mixture M from the inhalation device 100 through a mouthpiece 136 of the inhalation device 100) according to claim 15 (see claim 15 above).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 16, 17, 20 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Steelman (US 20130276781) in view of Bruin (GB 2494304).
Regarding claim 16, Steelman discloses
the nebulization cup (inhalation device/spacer 100) according to claim 15
Steelman does not disclose wherein a content of the antistatic agent added to the cup body is 0.03 %-10% in terms of mass percentage.
Bruin discloses an analogous metered dose inhaler with an antistatic spacer (abstract)
wherein a content of the antistatic agent (wherein the antimicrobial agent imparts antistatic properties to the plastic material; abstract and page 3, paragraphs 1 and 2) added to the cup body is 0.03 %-10% in terms of mass percentage (the plastic material comprises the antimicrobial/antistatic agent being greater than 0.5 wt% and less than 5 wt% (mass percentage); page 4, lines 11-22).
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 antistatic component on the plastic material of the sleeve member (cup body) of Steelman with the wt% of the antimicrobial/antistatic agent as disclosed in Bruin to prevent a low loading of the antimicrobial/antistatic agent that may not produce the desired antistatic effect while also preventing a high loading that may cause clouding of the plastic material leading to a less visually attractive spacer (Bruin: page 4, lines 11-22).
Regarding claim 17, the modified device of Steelman further discloses
the nebulization cup (Steelman: inhalation device/spacer 100; Bruin: mass percentage of antimicrobial/antistatic agent) according to claim 16,
wherein a content of the antistatic agent (Bruin: wherein the antimicrobial agent imparts antistatic properties to the plastic material; abstract and page 3, paragraphs 1 and 2) added to the cup body (Steelman: figs. 1-12; the sleeve member 180 is formed of a material which can include an antistatic component; [0080]-[0082]) is 0.05 %-5% in terms of mass percentage (Bruin: the plastic material comprises the antimicrobial/antistatic agent being greater than 0.5 wt% and less than 5 wt% (mass percentage); page 4, lines 11-22).
Regarding claim 20, Steelman discloses
the nebulization cup (inhalation device/spacer 100) according to claim 15,
wherein an antistatic agent is added to the cup lid (figs. 1-12; head 110 is formed of a polymer loaded, blended, mixed, or coated with a supplemental that enhances anti-static properties of the polymer; [0083]).
Steelman does not disclose a content of antistatic agent added to the cup lid is 0.03 %-10% in terms of mass percentage.
Bruin discloses an analogous metered dose inhaler with an antistatic spacer (abstract)
wherein a content of the antistatic agent (wherein the antimicrobial agent imparts antistatic properties to the plastic material; abstract and page 3, paragraphs 1 and 2) added to the cup lid is 0.03 %-10% in terms of mass percentage (the plastic material comprises the antimicrobial/antistatic agent being greater than 0.5 wt% and less than 5 wt% (mass percentage); page 4, lines 11-22).
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 antistatic component on the plastic material of the head (cup lid) of Steelman with the wt% of the antimicrobial/antistatic agent as disclosed in Bruin to prevent a low loading of the antimicrobial/antistatic agent that may not produce the desired antistatic effect while also preventing a high loading that may cause clouding of the plastic material leading to a less visually attractive spacer (Bruin: page 4, lines 11-22).
Regarding claim 21, the modified device of Steelman discloses
the nebulization cup (Steelman: inhalation device/spacer 100; Bruin: mass percentage of antimicrobial/antistatic agent) according to claim 15 (claim 21 is treated as being dependent off of claim 20, see 112b rejection above),
wherein the content of antistatic agent (Bruin: wherein the antimicrobial agent imparts antistatic properties to the plastic material; abstract and page 3, paragraphs 1 and 2) added to the cup lid (Steelman: figs. 1-12; head 110 is formed of a polymer loaded, blended, mixed, or coated with a supplemental that enhances anti-static properties of the polymer; [0083]) is 0.05 %-5% in terms of mass percentage (Bruin: the plastic material comprises the antimicrobial/antistatic agent being greater than 0.5 wt% and less than 5 wt% (mass percentage); page 4, lines 11-22).
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Steelman (US 20130276781) in view of Clements (US 20190125991).
Regarding claim 22, Steelman discloses
the nebulization cup (inhalation device/spacer 100) according to claim 15,
wherein the cup lid is provided with a suction nozzle (see figs. 1 and 7; the head 110 is provided with mouth piece 136; [0064]) and the inhalation device has a mist inlet (see figs. 1-7; the dispensing section 46 of the dispenser 15 can be inserted into inlet opening 104 of cover member 160; [0072]).
Steelman does not disclose wherein the cup lid is provided with the mist inlet.
However, Clements discloses an analogous metered dose inhaler with an antistatic coated bag (cup body)
wherein the cup lid (see figs. 10 and 14; body 118 is a lid for the antistatic bag 112 which forms a chamber 120; [0085]) is provided with a mist inlet and a suction nozzle (see figs. 10 and 14; body 118 comprises an inlet 114 where meter dose inhaler (MDI) 156 can be inserted, [0085], [0086], and [0090]; and outlet 116 that allows user to inhale the active drug, [0085], [0086], and [0092]).
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 inlet opening and head of Steelman with the configuration of placing the inlet on the body (lid) as disclosed in Clements as such placement assists in ensuring that the inhalant drug (shown as microdispersion droplets) is guided into and fully enters the chamber first rather than being passed directly through between inlet and outlet as would have been the case if they had been in register, i.e. when the angle would have been 180 degrees or thereabouts (Clements: [0091]). Additionally, since such a modification would simply involve merely moving the inlet opening to the head (lid) without changing the operation of the device, a rearrangement of parts is generally recognized as being within the level of ordinary skill in the art (see MPEP 2144.04).
Claims 23-25 are rejected under 35 U.S.C. 103 as being unpatentable over Steelman (US 20130276781) in view of Shiga (US 20160237288).
Regarding claim 23, Steelman discloses
the nebulization cup (inhalation device/spacer 100) according to claim 15,
Steelman does not explicitly disclose wherein the antistatic agent is one of or a combination of more than one of anionic antistatic agent, zwitterionic antistatic agent, non-ionic antistatic agent and polymer antistatic agent.
Shiga discloses an antistatic agent for sealing a structure
wherein the antistatic agent is one of or a combination of more than one of anionic antistatic agent, zwitterionic antistatic agent, non-ionic antistatic agent and polymer antistatic agent (examples of antistatic agent includes cationic, anionic antistatic agents, nonionic agents, amphoteric, and polymeric antistatic agents where these compounds may be used alone or in combination of two or more kinds thereof; [0054].
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 antistatic compound of the Steelman with the variety of antistatic agents such as the cationic, anionic, nonionic, amphoteric, and polymeric compound as disclosed in Shiga to prevent bleeding and release of the agent from the material; therefore, suppressing the decrease in antistatic function over time (Shiga: [0054]-[0058]).
Regarding claim 24, the modified device of Steelman further discloses
the nebulization cup (Steelman: inhalation device/spacer 100; Shiga: anionic, nonionic, and polymeric antistatic agents) according to claim 23,
wherein the anionic antistatic agent is one of or a combination of more than one of (Shiga: the different types of anionic antistatic agents/compounds may be used alone or in combination of two or more kinds thereof; [0056]) alkyl sulfonate, alkyl phosphate (Shiga: Examples of the anionic antistatic agent include alkyl sulfonate, alkylbenzene sulfonate, alkylsulfate, alkylethoxysulfate, alkyl phosphate, and a sulfonic acid group-containing styrene copolymer; [0056]), copolymer salt of maleic anhydride and other monomer copolymer salts, polyacrylates and polystyrene sulfonates;
the zwitterionic antistatic agent is amphoteric alkyl imidazoline salt and alkyl amino acid;
the nonionic antistatic agent is one of or a combination of more than one of (Shiga: the different types of nonionic antistatic agents/compounds may be used alone or in combination of two or more kinds thereof; [0058]) polyhydroxy alcohol fatty acid ester (Shiga: examples of the nonionic antistatic agent include fatty acid glycerol ester, sorbitan fatty acid ester, polyoxysorbitan fatty acid ester (types of polyhydroxy alcohol fatty acid ester); [0058]) and polyoxyethylene additive (Shiga: examples of the nonionic antistatic agent include polyoxyethylene alkylamine, polyoxyethylene glycol fatty acid ester, polyoxyethylene alkylphenylether, polyoxyethylene alkylether, and polyoxyethylene diamine; [0058]);
the polymer antistatic agent is one of or a combination of more than one of polyoxyethylene fatty ether, polyoxyethylene alkylbenzene ether, polyethylene glycol fatty acid ester and polyacrylic acid derivative.
Regarding claim 25, the modified device of Steelman further discloses
the nebulization cup (Steelman: inhalation device/spacer 100; Shiga: anionic, nonionic, and polymeric antistatic agents) according to claim 23,
wherein the non-ionic antistatic agent mentioned is selected from one of or a combination of more than one of fatty alcohol ethoxylates (Shiga: examples of the nonionic antistatic agent include polyoxyethylene alkylether; [0058]), alkyl phenol ethoxylates (Shiga: examples of the nonionic antistatic agent include polyoxyethylene alkylphenylether; [0058]), and mono- and di-glycerides of fatty acids (Shiga: examples of the nonionic antistatic agent include fatty acid glycerol ester; [0058]);
the amphoteric antistatic agent is alkyl dicarboxymethyl ammonium succinimide and/or dodecyl dimethyl betaine;
the polymeric antistatic agent is selected from one of or a combination of more than one of ethylene oxide-propylene oxide adducts of ethylenediamine, poly(4- vinylpyridine) type polymeric soaps, octylphenyl styrenes, and styrene sulfonate copolymeric soaps.
Claims 26 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Steelman (US 20130276781).
Regarding claim 26, Steelman further disclose
the nebulization cup (inhalation device/spacer 100) according to claim 15,
wherein the nebulization cup has a volume of 300-800 ml (figs. 1-7; the chamber 102 of the inhalation device 100 has a volume in the range of about 200 to 800 ml; [0073] and [0092]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have a volume in the range of 300-800 ml since this falls within the workable volume of 200-800 ml.
Regarding claim 27, Steelman further disclose
the nebulization cup (inhalation device/spacer 100) according to claim 26,
wherein the nebulization cup has a volume of 500 ml (figs. 1-7; the chamber 102 of the inhalation device 100 has a volume in the range of about 200 to 800 ml; [0073] and [0092]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have a volume of 500 ml since this falls within the workable volume of 200-800 ml.
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Steelman (US 20130276781) in view of Geiger (US 20080210225).
Regarding claim 30, Steelman discloses
the method (method of using an inhalation device to convert medications for treatment) according to claim 29,
Steelman does not explicitly disclose wherein the drug is a vaccine.
However, Geiger discloses an analogous medicinal inhalant device with a disposable antistatic spacer
wherein the drug is a vaccine (figs. 1, 2, 10, and 12; administration of pharmaceuticals; including antibiotics, vaccines and bronchodilators; abstract, [0021], [0033], and [0079]; vaccines are delivered with mass inoculation pump 50; connected to tube 52 of inhalant device).
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 inhalant device of Steelman to be attachable with a mass inoculation pump as disclosed in Geiger that better facilitates dispensing of inhalant medications, vaccines and dry powdered medicants more effectively, is a safer device that offers the modern antibacterial benefit of disposability after one or numerous applications, is an innovative platform for other pulmonary therapeutic devices, and is able to efficiently administrate a large group or mass vaccinations using a needle free delivery device (Geiger: abstract, [0021], and [0079]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Snyder (US 20080257345) – An aerosol medication delivery apparatus where the holding chamber is made of a plastic material and comprises an antistatic component
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/S.R.R./Examiner, Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785
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