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,
Claim 1, lines 17-18: “an inlet side side at the aerosol side.
Claim 1, line 19: “an outlet side”.
must be shown or the feature(s) canceled from the claim(s). 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.
Claim Objections
Claim 8 is objected to because of the following informalities:
Claim 8, line 3 recites “between 1,5 µm to 5 µm” shall be corrected to “between 1.5 µm to 5 µm” for clarity.
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.
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 sealing surface” in claims 3 and 4.
Because this/these claim limitations 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 these limitations interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitations to avoid 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.
Claim limitation “the sealing surface” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function.
Claim 3, lines 7 and 9 and claim 4, line 2 recites “sealing surface (38)”. However, in the specifications and drawings, label 38 is referred to as “top of the circumferential rim” For the purposes of examination, “sealing surface” will be interpreted as the top of the circumferential rim.
Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claims 1 and 3 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.
Regarding Claim 1, line 12 recites “and an outlet (94) at an outlet side for administering the aerosol” however this statement lacks clarity as to what outlet side the applicant is referring to. For the purposes of examination, the “outlet side” will be interpreted to refer to the outlet side of the aerosol side of the vibratable membrane.
Regarding Claim 3, line 3 recites “a body sealed at a lower portion” however it is unclear what is considered the lower portion of the body. For the purposes of examination, the “lower portion” will be interpreted as the outlet of the reservoir.
Claim 3 recites the limitation "the sealed lower portion" in lines 11-12. There is insufficient antecedent basis for this limitation in the claim.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance,
Claim 12 recites the broad recitation “has a viscosity of 0.900 to 5.000 mPaes” in, and the claim also recites “preferred from 0.950 to 3.500 mPaes” and “more preferred from 1.000 to 2.000 mPaes” which are the narrower statements of the range/limitation.
Claim 13 recites the broad recitation “has a surface tension of of 32 mN/m to 108mN/m”, and the claim also recites “or preferred of 37 mN/m to 73 mN/m” which is the narrower statement of the range/limitation.
Claim 14 recites the broad recitation “an osmolality of 200 mOsm/kg to 700 mOsm/kg”, and the claim also recites “preferred 200 mOsm/kg to 500 mOsm/kg” which is the narrower statement of the range/limitation.
Claim 16 recites the broad recitation “the volume of the reservoir (24) is between 1 ml and 5m1”, and the claim also recites “preferably between 3ml and 5m1” which is the narrower statement of the range/limitation.
The claims are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
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 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 1-4 and 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Gallem et al (US 20170232211 A1), in view of Rosser et al (US 20200138113 A1).
Regarding claim 1, Gallem discloses a drug-device combination comprising [0071]
a liquid solution (fluid 6) containing a biologic [Abstract and 0074]; and
a nebulizer (aerosol delivery device 1) for aerosolization of the liquid solution (liquid 6), the nebulizer comprising (Figs. 7-8; [0183]):
a vibratable membrane (44) having an active area with apertures (holes not shown), wherein the liquid solution (liquid 6) is feedable to the active area at a liquid side of the membrane (Figs. 7-8 and 9a-9b; [0180-0186]);
a piezoelectric actuator (not shown) for vibrating the membrane (44), whereby an aerosol of the liquid solution (liquid 6) is generated at the active area at an aerosol side of the membrane, the aerosol side of the membrane being opposite to the liquid side of the membrane (Figs. 7-8 and 9a-b; [0180-0186]);
a plenum chamber (aerosol chamber 3) having an inlet at an inlet side at the aerosol side of the membrane (44) and an outlet at an outlet side for administering the aerosol, the outlet of the plenum chamber being opposite to the inlet of the plenum chamber.
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However, Gallem fails to disclose a reservoir for holding the liquid solution, the reservoir having a vent for maintaining atmospheric pressure in the reservoir.
Rosser teaches a reservoir (storage chamber 204) for holding the liquid solution (vaporizable material 210), the reservoir having a vent (211) for maintaining atmospheric pressure in the reservoir to substantially maintain an inner pressure (Fig. 2A; [0075 and 0099].
Therefore, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify Gallem so that, a reservoir for holding the liquid solution, the reservoir having a vent for maintaining atmospheric pressure in the reservoir, as taught by Rosser, in order to substantially maintain an inner pressure.
Regarding claim 2, modified Gallem discloses the drug-device combination of claim 1, as mentioned above.
Modified Gallem further discloses wherein the vent (211) is a passive vent as there is no mention of active components.
Regarding claim 3, modified Gallem discloses the drug-device combination of claim 1, as mentioned above.
Modified Gallem further discloses wherein the reservoir (2) is a cup reservoir defined by a body (threaded collar 21) sealed at a lower portion by the vibratable membrane (44) (Gallem: Figs. 9a-b; [0192]);
the body (threaded collar 21) having a circumferential rim defining an opening (filing port 16) for receiving the liquid solution (fluid 6) and a sealing surface (Gallem: Figs. 1-2 and 5-6);
a lid (17) for engaging the circumferential rim to close the reservoir (2) and sealing against the sealing surface (Gallem: Figs. 1-2 and 9a-b; [0183]);
the vent (211) connecting a head space of the reservoir (storage chamber 204) to atmosphere and being spaced away from the sealed lower portion (Rosser: Fig. 2A; [0075 and 0099]).
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Regarding claim 4, modified Gallem discloses the drug-device combination of claim 3, as mentioned above.
Modified Gallem further discloses wherein the vent is a notch formed from the sealing surface into the circumferential rim and traversing the circumferential rim connecting the interior of the reservoir and atmosphere because it would be obvious to rearrange the notch/vent as the rearrangement would not have modified the function of the notch/vent to substantially maintain an inner pressure (Example. In re Japikse).
Regarding claim 15, Gallem discloses the drug-device combination of claim 1, as mentioned above.
Gallem further discloses wherein the amount of the liquid solution (26) of one dose is between 1ml and 2m1 [0063] as the prior art’s specified volumes fall within applicant’s claimed range.
Regarding claim 16, Gallem discloses the drug-device combination of claim 1, as mentioned above.
Gallem further discloses wherein the volume of the reservoir (24) is between 1 ml and 5m1, preferably between 3ml and 5m1 [0023] as the prior art’s specified volumes fall within applicant’s claimed range.
Regarding claim 17, Gallem discloses the drug-device combination of claim 1, as mentioned above.
Gallem further discloses wherein the biologic comprises one or more proteins and preferred two or more proteins [0074].
Claims 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Gallem and Rosser, in further view of Fink (US 20050229926 A1).
Regarding claim 5, modified Gallem discloses the drug-device combination of claim 1, as mentioned above.
However, modified Gallem fails to disclose wherein the plenum chamber has a volume of at least 60 cubic centimeters.
Fink teaches wherein the plenum chamber (23) has a volume of at least 60 cubic centimeters, as the prior art’s specified volumes fall within applicant’s claimed range, to allow a concentration of surfactant aerosol to be collected that is higher than the concentration that is generated by the aerosol generator alone, prior to being discharged into the respiratory circuit.
Therefore, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to further modify modified Gallem so that, wherein the plenum chamber has a volume of at least 60 cubic centimeters, as taught by Fink, in order to allow a concentration of surfactant aerosol to be collected that is higher than the concentration that is generated by the aerosol generator alone, prior to being discharged into the respiratory circuit.
Regarding claim 6, modified Gallem discloses the drug-device combination of claim 1, as mentioned above.
However, modified Gallem fails to disclose wherein the plenum chamber has a volume of not more than 90 cubic centimeters.
Fink teaches wherein the plenum chamber (23) has a volume of not more than 90 cubic centimeters, as the prior art’s specified volumes fall within applicant’s claimed range, to allow a concentration of surfactant aerosol to be collected that is higher than the concentration that is generated by the aerosol generator alone, prior to being discharged into the respiratory circuit.
Therefore, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to further modify modified Gallem so that, wherein the plenum chamber has a volume of not more than 90 cubic centimeters, as taught by Fink, in order to allow a concentration of surfactant aerosol to be collected that is higher than the concentration that is generated by the aerosol generator alone, prior to being discharged into the respiratory circuit.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Gallem and Rosser, in further view of Dionne (US 20050092325 A1).
Regarding claim 7, modified Gallem discloses the drug-device combination of claim 1, as mentioned above.
However, modified Gallem fails to disclose wherein the plenum chamber has a length between 109mm and 154mm, and/or a width of 40mm and 60mm and/or a height of 30mm and 50mm.
Dionne teaches wherein the plenum chamber (nebulizer tube 10) has a length between 109mm and 154mm (Fig. 2; [0024]), and/or a width of 40mm and 60mm and/or a height of 30mm and 50mm, as the prior art’s specified volumes fall within applicant’s claimed range, so that the nebulizer device be maintained fairly close to the patients face [0024].
Therefore, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to further modify modified Gallem so that wherein the plenum chamber has a length between 109mm and 154mm, and/or a width of 40mm and 60mm and/or a height of 30mm and 50mm., as taught by Dionne, so that the nebulizer device be maintained fairly close to the patients face.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Gallem and Rosser, in further view of Allosery (US 10512739 B2).
Regarding claim 8, modified Gallem discloses the drug-device combination of claim 1, as mentioned above.
However, modified Gallem fails to disclose wherein the apertures have a size at the aerosol side between 1,5 µm to 5 µm.
Allosery teaches wherein the apertures have a size at the aerosol side between 1,5 µm to 5 µm (Summary [19]), as the prior art’s specified volumes fall within applicant’s claimed range, for a particularly fine aerosol mist (Detailed Description [19]).
Therefore, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to further modify modified Gallem so that wherein the apertures have a size at the aerosol side between 1,5 µm to 5 µm., as taught by Allosery, for a particularly fine aerosol mist.
Claims 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Gallem and Rosser, in further view of Schulz (US 20140263721 A1).
Regarding claim 9, modified Gallem discloses the drug-device combination of claim 1, as mentioned above.
However, modified Gallem fails to disclose wherein the vibratable membrane comprises 500 to 6000 apertures.
Schulz teaches wherein the vibratable membrane (22) comprises 500 to 6000 apertures (through holes 26), as the prior art’s specified volumes fall within applicant’s claimed range, so that the total output rate may be further increased (Figs. 1-2; [0018 and 0033]).
Therefore, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to further modify modified Gallem so that, wherein the vibratable membrane comprises 500 to 6000 apertures, as taught by Schulz, so that the total output rate may be further increased.
Regarding claim 10, modified Gallem discloses the drug-device combination of claim 1, as mentioned above.
However, modified Gallem fails to disclose wherein the apertures are laser drilled and/or laser milled.
Schulz teaches wherein the apertures (through holes 26) are laser drilled and/or laser milled [0027] so that the through holes are substantially cylindrical or conical [0034].
Therefore, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to further modify modified Gallem so that, wherein the apertures are laser drilled and/or laser milled, as taught by Schulz, so that the through holes are substantially cylindrical or conical.
Regarding claim 11, modified Gallem discloses the drug-device combination of claim 1, as mentioned above.
However, modified Gallem fails to disclose wherein the apertures have a nozzle portion at the aerosol side of the active area of the membrane, the nozzle portion having a length of less than 20 µm.
Schulz teaches wherein the apertures (through holes 26) have a nozzle portion (32) at the aerosol side of the active area of the membrane (22), the nozzle portion having a length of less than 20 µm (Fig.2; [0014 and 0027]), as the prior art’s specified volumes fall within applicant’s claimed range, as it has a significant influence on the total output rate of the aerosol generators [0008].
Therefore, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to further modify modified Gallem so that, wherein the apertures have a nozzle portion at the aerosol side of the active area of the membrane, the nozzle portion having a length of less than 20 µm, as taught by Schulz, in order to have a significant influence on the total output rate of the aerosol generators
Claims 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over Gallem and Rosser, in further view of Keller (US 20140366872 A1).
Regarding claim 12, modified Gallem discloses the drug-device combination of claim 1, as mentioned above.
However, modified Gallem fails to disclose wherein the liquid solution has a viscosity of 0.900 to 5.000 mPaes, preferred from 0.950 to 3.500 mPaes, more preferred from 1.000 to 2.000 mPaes.
Keller teaches wherein the liquid solution has a viscosity of 0.900 to 5.000 mPaes, preferred from 0.950 to 3.500 mPaes, more preferred from 1.000 to 2.000 mPaes, as the prior art’s specified volumes fall within applicant’s claimed range, for particle size distribution of the aerosol formed by nebulisation and on the efficiency of nebulisation [0087].
Therefore, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to further modify modified Gallem so that, wherein the liquid solution has a viscosity of 0.900 to 5.000 mPaes, preferred from 0.950 to 3.500 mPaes, more preferred from 1.000 to 2.000 mPaes, as taught by Keller, for particle size distribution of the aerosol formed by nebulisation and on the efficiency of nebulization.
Regarding claim 13, modified Gallem discloses the drug-device combination of claim 1, as mentioned above.
However, modified Gallem fails to disclose wherein the liquid solution has a surface tension of of 32 mN/m to 108mN/m or preferred of 37 mN/m to 73 mN/m.
Keller teaches wherein the liquid solution has a surface tension of of 32 mN/m to 108mN/m or preferred of 37 mN/m to 73 mN/m, as the prior art’s specified volumes fall within applicant’s claimed range, to effectively be delivered to the mucosal surfaces [0086].
Therefore, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to further modify modified Gallem so that wherein the liquid solution has a surface tension of of 32 mN/m to 108mN/m or preferred of 37 mN/m to 73 mN/m, as taught by Keller, in order to effectively be delivered to the mucosal surfaces.
Regarding claim 14, modified Gallem discloses the drug-device combination of claim 1, as mentioned above.
However, modified Gallem fails to disclose wherein the liquid solution has an osmolality of 200 mOsm/kg to 700 mOsm/kg, preferred 200 mOsm/kg to 500 mOsm/kg.
Keller teaches wherein the liquid solution has an osmolality of 200 mOsm/kg to 700 mOsm/kg, preferred 200 mOsm/kg to 500 mOsm/kg, as the prior art’s specified volumes fall within applicant’s claimed range, in order to be well-tolerated [0063].
Therefore, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify further modify modified Gallem so that wherein the liquid solution has an osmolality of 200 mOsm/kg to 700 mOsm/kg, preferred 200 mOsm/kg to 500 mOsm/kg, as taught by Keller, in order to be well-tolerated.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Gallem and Rosser, in further view of Heslet (US 20150174204 A1).
Regarding claim 18, modified Gallem discloses the drug-device combination of claim 17, as mentioned above.
However, modified Gallem fails to disclose wherein one of the proteins is granulocyte-macrophage colony stimulating factor (GM-CSF) and preferred is recombinant human granulocyte-macrophage colony stimulating factor (rhGM-CSF).
Heslet teaches wherein one of the proteins is granulocyte-macrophage colony stimulating factor (GM-CSF) and preferred is recombinant human granulocyte-macrophage colony stimulating factor (rhGM-CSF) to treat bronchial asthma [Abstract and 0030].
Therefore, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify modified Gallem so that wherein one of the proteins is granulocyte-macrophage colony stimulating factor (GM-CSF) and preferred is recombinant human granulocyte-macrophage colony stimulating factor (rhGM-CSF) to treat bronchial asthma, as taught by Heslet, in order to treat bronchial asthma.
Response to Amendment
The claims currently pending and examined herein are the claims of record as amended on September 19, 2024. The later-filed April 16, 2025 submission is understood to include a clean copy of the specification and an erroneously included duplicate version of the originally filed claims, which does not appear to supersede the previously entered amendments. For purposes of examination, the Examiner relies on the claims properly of record and entered as pending, filed September 19,2024. Applicant is reminded to ensure that any future amendments accurately reflect the currently pending claim set.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Gallem et al (US 20110146670 A1) is cited for its nebulizer. (Figs. 1 and 4)
Finke et al (US 20160310681 A1) is cited for its aerosol delivery device. (Fig. 1)
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMIRAH WRIGHT whose telephone number is (571)270-1946. The examiner can normally be reached M-Th: 6:45AM-4:15PM F: 6:45AM-3:15PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brandy S Lee can be reached at (571) 270-7410. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AMIRAH WRIGHT/Examiner, Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785
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