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 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.
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:
“Module” in claim 26.
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 Objections
Claims 30 – 31, 33, 35, 38, 40, 42 & 44 objected to because of the following informalities:
Claims 30 – 31, 33, 35, 38, 40, 42 & 44 should be dependent on claim 28 in order to have antecedent basis of the structure of the module.
Appropriate correction is required.
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.
Claim(s) 26, 28, 30 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al (EP 4265287 A1) in view of Yeates et al. (CN 109562237 A).
Regarding claim 26, A metered-dose atomizer comprising a metered-dose atomization module of the atomizer, wherein the metered-dose atomizer is an atomizer. (Abstract)
Zhang does not disclose quantitatively atomize 5 μL-60 μL in 1s-3s.
Yeates discloses quantitatively atomize 5 μL-60 μL in 1s-3s. (P
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date to modify to include quantitatively atomize 5 μL-60 μL in 1s-3s as having the fluid to be aerosolized may be aerosolized at rates between 100ul and 3ml/minutes (i.e. 1.67ul - 50 ul/s) to allow the liquid to pass between a membrane or mesh
Regarding claim 27, Modified Zhang discloses the metered-dose atomizer as claimed in claim 26.
Modified Zhang does not disclose wherein the percentage of droplets with an aerodynamic particle size of less than 5.8 pm in the atomizer to the total mass of the droplets is more than 65%.
Furthermore, since applicants have not disclosed that these modifications solve any stated problem or are for any particular purpose and it appears that the device would perform equally well with either designs, these modifications are a matter of design choice. Absent a teaching as to criticality of the percentage of droplets, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA 1975). MPEP 2144.05.
Regarding claim 28, Modified Zhang discloses the metered-dose atomizer as claimed in claim 26, wherein the metered-dose atomization module comprises:
a spray head 15, providing with an atomization cavity (see annotated Figure 2) with a step surface 114;
an atomization piece (see annotated Figure 2), which comprises an annular brake 110 and a microporous membrane 12 attached to the side surface of the annular brake 110;
rubber rings, which comprise a first sealing ring 111 and a second sealing ring 115 (Paragraph 0033, line 10 – 11 & Paragraph 0038, lines 25 - 27), the first sealing ring 111 and the second sealing ring 115 are both annular and clamped on both sides of the atomization piece (see annotated Figure 2) respectively (Figure 2); and
a pressing plate 14, which is annular and fixed (Note: the examiner considers this to not be direct) with the spray head 15, and is adapted to cooperate with the step surface 114 to install the atomization piece (see annotated Figure 2) and the rubber rings 111 & 115 in the atomization cavity.
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Figure 2: Annotated Figure 2 of App. EP 4265287 A1
Regarding claim 29, Modified Zhang discloses the metered-dose atomizer as claimed in claim 26.
Modified Zhang discloses wherein the microporous membrane 12 of the metered-dose atomization module comprises a central area 1114 covering the central hole of the annular brake 110 (Paragraph 0038), and an adhesive area 114 connected to the annular brake 110 (Paragraph 0033); and the internal stress of the microporous membrane remains constant before and after connecting (Note: the examiner considers as the device does not deform it maintains the same internal stress).
Regarding claim 30, Modified Zhang discloses the metered-dose atomizer as claimed in claim 26.
Modified Zhang discloses wherein the central area of the metered-dose atomization module 12 comprises a micropore area densely covered with micropores, and an outer ring area 30 surrounding the periphery of the micropore area, the total surface curvature change of the micropore area is larger than that of the outer ring area (Paragraph 0031 discloses the micropore area is the same diameter as the mounting groove).
Regarding claim 32, Modified Zhang discloses the metered-dose atomizer as claimed in claim 26.
Modified Zhang does not disclose wherein the side surface of the pressing plate of the metered-dose atomization module is further provided with a positioning ring coaxially arranged with the pressing plate; the outer diameter of the positioning ring is larger than or equal to the outer diameter of the second sealing ring, and the inner diameter is smaller than or equal to the inner diameter of the second sealing ring, which is suitable for corresponding press fit with the first sealing ring.
Furthermore, since applicants have not disclosed that these modifications solve any stated problem or are for any particular purpose and it appears that the device would perform equally well with either designs, these modifications are a matter of design choice. Absent a teaching as to criticality of positioning ring positioning, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA 1975). MPEP 2144.05.
Claim 31 is rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al (EP 4265287 A1) in view of Yeates et al. (CN 109562237 A) as claimed in claim 26, in further view of Zhu, B., Duke, M., Dumée, L. F., Merenda, A., Des Ligneris, E., Kong, L., Hodgson, P. D., & Gray, S. (2018). Short Review on Porous Metal Membranes—Fabrication, Commercial Products, and Applications. Membranes, 8(3), 83. [Retrieved from: https://doi.org/10.3390/membranes8030083] & ePowerMetals. (2020-10-17) Commonly used HV-HB-HRC hardness comparison table. [Retrieved from: https://www.epowermetals.com/commonly-used-hv-hb-hrc-hardness-comparison-table.html)
Regarding claim 31, Modified Zhang discloses the metered-dose atomizer as claimed in claim 26.
Modified Zhang discloses wherein at least one of:(i) the microporous membrane 12 of the metered-dose atomization module is made of metal material. (Paragraph 0032)
Modified Zhang does not disclose the material is stainless steel and the Vickers hardness of the stainless-steel material is 200-500 HV.
Zhu discloses the use of microporous metal membranes. (Page 8, last paragraph)
However, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing ate to further modify Zhang to modify the metal material of the microporous membrane of Zhang to be stainless steel as membrane-based processes have become increasingly attractive due to their ability to reliably remove contaminants, their affordability, and the increasing prominence of energy and water issues necessitating efficient treatment of waste effluents. (Page 3, Paragraph 2) Metal membranes offer some advantages over the polymeric membranes for these applications because the modules can be cleaned by high pressure back-flushing, thus reducing the use and influence of cleaning chemicals. (Page 3, Paragraph 4) Also, it is stated that stainless steel (SS) is the most commonly used for producing porous metal membranes by particle sintering. (Page 4, Paragraph 1)
ePower Metals discloses the Vickers hardness test. (Page 9, last paragraph – Page 10, Paragraph 1)
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date to further modify the hardness of the metal material of Zhang as the vicker hardness measures the thinner materials and surface hardening layers. Since applicants have not disclosed that these modifications solve any stated problem or are for any particular purpose and it appears that the device would perform equally well with either designs, these modifications are a matter of design choice. Absent a teaching as to criticality of the Vickers hardness of the stainless-steel material is 200-500 HV, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA 1975). MPEP 2144.05. There is no indication of why the metal must have that specific range of hardness, however, it would be obvious to have a large hardness number as it means the surface is hard.
Claim(s) 33 – 34 & 38 – 41 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al (EP 4265287 A1) in view of Yeates et al. (CN 109562237 A) as claimed in claim 32, in further view of Rubin et al. (US 20170368273 A1).
Regarding claim 33, Modified Zhang discloses the metered-dose atomizer as claimed in claim 32.
Modified Zhang discloses wherein further comprising:
a medicine bottle 2, which is detachably connected to the inlet 13 of the atomization cavity (see annotated Figure 2) in the spray head 15 (Paragraph 0052);
a shell 10, which comprises a neck shell (see annotated Figure 2.1) and a main shell (see annotated Figure 2.1), the neck shell (see annotated Figure 2.1) is located on the outside of the medicine bottle 2 (Figure 1), and one end is connected with the spray head 15, and the other end is connected with the main shell (see annotated Figure 2.1) (Paragraph 0026); and
a driving device 35, which is located in the main shell and is electrically connected with the atomization piece (see annotated Figure 2) (Paragraph 0061).
Modified Zhang does not disclose a curved neck shell.
Rubin discloses a curved neck shell. (Paragraph 0043)
It would have been obvious to one of ordinary skill in the art prior to the effective filing date to further modify the neck shell of Zhang to be curved as it would contour the users’ lips allowing for an airtight seal. (Paragraph 0046)
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Figure 2.1: Annotated Figure 2.1 of App. EP 4265287 A1
Regarding claim 34, Modified Zhang discloses the metered-dose atomizer as claimed in claim 33.
Modified Zhang discloses wherein the driving frequency of the driving device 35 is the natural frequency of the atomization piece. (Paragraph 0061 – 0062)
Regarding claim 38, Modified Zhang discloses a spray assembly comprising spray and a metered-dose atomizer as claimed in claim 26.
Modified Zhang does not disclose wherein the active pharmaceutical ingredient in the spray comprises at least one of prostacyclin.
Rubin further discloses wherein the active pharmaceutical ingredient in the spray comprises at least one of prostacyclin. (Paragraph 0055)
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date to further modify the active pharmaceutical ingredient in the spray of Zhang to include at least one of prostacyclin as it treats pulmonary arterial hypertension. (Paragraph 0055)
Regarding claim 39, Modified Zhang discloses a method for treating pulmonary arterial hypertension in a human in need thereof (Rubin, Paragraph 0055), wherein the method comprises administering to the human a spray assembly as claimed in claim 38.
Regarding claim 40, Modified Zhang discloses a spray assembly comprising spray and a metered-dose atomizer as claimed in claim 26.
Rubin further discloses wherein the active pharmaceutical ingredient in the spray comprises antibiotic drug, the antibiotic comprises at least one of tobramycin, amikacin (Paragraph 0131).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date to further modify Zhang to include wherein the active pharmaceutical ingredient in the spray comprises antibiotic drug, the antibiotic comprises at least one of tobramycin, amikacin as they are known antibiotic active pharmaceutical ingredients that are able to be used for aerolization in the device. (Paragraph 0131)
Regrading claim 41, Rubin further discloses a method for treating lung infection in a human in need thereof (Paragraph 0055), wherein the method comprises administering to the human a spray assembly of claim 40.
Claim(s) 35 & 37 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al (EP 4265287 A1) in view of Yeates et al. (CN 109562237 A) as claimed in claim 26, in further view of Germinario et al. (US 20170319797 A1).
Regarding claim 35, Modified Zhang discloses a spray assembly comprising spray and the metered-dose atomizer as claimed in claim 26.
Modified Zhang discloses liquid medicine. (Abstract)
Modified Zhang does not disclose wherein the active pharmaceutical ingredient in the spray comprises at least one of muscarinic receptor antagonist.
Germinario discloses wherein the active pharmaceutical ingredient in the spray comprises at least one of muscarinic receptor antagonist. (Paragraph 0225)
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date to further modify Zhang to include wherein the active pharmaceutical ingredient in the spray comprises at least one of muscarinic receptor antagonist as it is known as a medicine treatment for COPD patients. (Paragraph 0225)
Regarding claim 37, Modified Zhang discloses a method for treating COPD (chronic obstructive pulmonary disease) and/or asthma in a human in need thereof, wherein the method comprises administering to the human a spray assembly (Abstract) as claimed in claim 35.
Claim(s) 36 is rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al (EP 4265287 A1) in view of Yeates et al. (CN 109562237 A) & Germinario et al. (US 20170319797 A1) as claimed in claim 35, Gallagher et al. (WO 2019030602 A1).
Regarding claim 36, Modified Zhang discloses spray assembly as claimed in claim 35.
Modified Zhang does not disclose wherein at least one of: (2) the glucocorticoids comprise at one least of dexamethasone.
Gallagher discloses wherein at least one of: (2) the glucocorticoids comprise at one least of dexamethasone. (Page 12, lines 26 – 27)
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date to further modify Zhang to include wherein at least one of: (2) the glucocorticoids comprise at one least of dexamethasone as glucocorticoids is a known therapy that includes dexamethasone (Page 12, lines 26 – 27)
Claim(s) 42 – 43 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al (EP 4265287 A1) in view of Yeates et al. (CN 109562237 A) as claimed in claim 26, in further view of Rosser et al. (WO 2020157506 A1).
Regarding claim 42, Modified Zhang discloses a spray assembly comprising spray and a metered-dose atomizer as claimed in claim 26.
Modified Zhang does not disclose wherein the active pharmaceutical ingredient in the spray comprises at least one of pirfenidone and nintedanib.
Rosser discloses wherein the active pharmaceutical ingredient in the spray comprises at least one of pirfenidone and nintedanib. (Page 18, lines 9 – 11 / Page 19, lines 11 – 15)
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date to further modify Zhang to include wherein the active pharmaceutical ingredient in the spray comprises at least one of pirfenidone and nintedanib as it is known as a suitable respiratory drug that would be active ingredients in cystic fibrosis drugs. (Page 18, lines 9 – 11)
Regarding claim 43, Rosser further discloses a method for treating idiopathic pulmonary fibrosis in a human in need thereof (Page 18, lines 9 – 11), wherein the method comprises administering to the human a spray assembly of claim 42.
Claim(s) 44 – 45 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al (EP 4265287 A1) in view of Yeates et al. (CN 109562237 A) as claimed in claim 26, in further view of Rigas et al. (EP 2711006 A1).
Regarding claim 44, Modified Zhang discloses a spray assembly comprising spray and a metered-dose atomizer as claimed in claim 26.
Modified Zhang does not disclose wherein the active pharmaceutical ingredient in the spray comprises a small molecule cytotoxic drug or a biological agent.
Rigas discloses wherein the active pharmaceutical ingredient in the spray comprises a small molecule cytotoxic. (Paragraph 0027)
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date to further modify Zhang to include wherein the active pharmaceutical ingredient in the spray comprises a small molecule cytotoxic drug or a biological agent as it is the cytotoxic drug is known as an anti-cancer agent which comprises said drug. (Paragraph 0027)
Regarding claim 45, Rigas further discloses a method for treating lung cancer in a human in need thereof (Paragraph 0027), wherein the method comprises administering to the human a spray assembly of claim 44.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GRACIELA NATALIA LEBRON DE JESUS whose telephone number is (571)270-3892. The examiner can normally be reached Mon - Fri 8:00-5:00 CST.
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/GRACIELA NATALIA LEBRON DE JESUS/Examiner, Art Unit 3785
/KENDRA D CARTER/Supervisory Patent Examiner, Art Unit 3785
