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 .
Response to Amendment
This office action is responsive to the amendment filed on February 2, 2026. As directed by the amendment: claim 16 has been amended, no claims have been canceled, and no new claims have been added. Thus, claims 1-22 are presently pending in the application.
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 8, 9, 11, and 12 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.
As to claim 8, lines 1-2 recite “The inhaler of claim 7, wherein each of x, y, and z of Formula (Ic) are 1. However, according to claim 7, “z is 2, 3, or 4” and thus, cannot be 1. For examination purposes, Examiner assumes that x and y are 1, but z remains as 2, 3, or 4.
As to claim 9, line 1 recites “The inhaler of claim 7, wherein y of Formula (Ic) is 0. However, according to claim 7, “y is 1 or 2” and thus, cannot be 0. For examination purposes, Examiner assumes that y remains 1 or 2.
As to claim 11, line 1 recites “The inhaler of claim 5, wherein n is an integer from 1 to 4”. However, n has not been introduced yet in claim 5. For examination purposes, Examiner assumes that 11 depends from claim 10.
As to claim 12, line 1 recites “The inhaler of claim 5, wherein Z is a …”. However, Z has not been introduced yet in claim 5. For examination purposes, Examiner assumes that 12 depends from claim 10.
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.
Claims 1-22 are rejected under 35 U.S.C. 103 as being unpatentable over Zhu et al. (US 2018/0071231).
As to claim 1, Zhu discloses an inhaler comprising:
a valve having a valve volume of no more than 40 microliters (µL) (paragraph [0033], last four lines – typical valve sizes range from 20µL to 35 µL);
a valve coating on at least a portion of the valve (paragraph [0049]), the coating comprising the condensation product of a first layer on the valve (primer) and a second layer (coating) on the first layer (paragraph [0051]-[0057]);
the first layer comprising a silane having one or more reactive silane groups (paragraph [0053]), and
the second layer comprising a polyfluoropolyether silane (paragraph [0054],[0063]);
a pressurized canister in fluid communication with the valve (paragraph [0033]), the pressurized canister containing a pharmaceutically acceptable inhalable composition that comprises
a propellant (paragraph [0021]); and
an active agent consisting of albuterol, one or more pharmaceutically acceptable salts thereof, or one or more pharmaceutically acceptable hydrates of any of the foregoing (paragraph [0014]; it is noted that the language of the claim requires the active agent recited to consist of albuterol, but the composition comprises a propellent and an active agent. In other words, while the active agent cannot have other components, the composition allows for other active agents or components to be included in the composition).
As to the limitation that free albuterol is present in a concentration of 2 milligrams/milliliter (mg/mL) or greater, Zhu discloses:
[0011] When the concentration of albuterol is discussed in this application, for convenience it is referred to in terms of the concentration of the form of albuterol that is most commonly used in this disclosure, that is, albuterol sulfate. It should therefore be understood that if another form or salt of albuterol is used, the concentration of that other form or salt should be calculated on a basis relative to albuterol sulfate. A person of ordinary skill in the relevant arts can easily perform this calculation by comparing the molecular weight of the form or salt of albuterol that is used to the molecular weight of albuterol sulfate.
[0017] The albuterol, such as albuterol sulfate, can be present in any suitable concentration in the formulation. When the concentration of albuterol is expressed in terms of mg/mL, then the concentration of albuterol can be… from 4 mg/mL to 11 mg/mL.
Thus, taking the molecular weight of albuterol sulfate (576.7) and the molecular weight of free base albuterol (239.3), the concentration range of 4-11 mg/mL of albuterol sulfate can be converted into a free base albuterol concentration range of 1.7 mg/mL to 4.6 mg/mL, which overlaps the claimed range. Therefore, a prima facie case of obviousness exists (see MPEP 2144.05 I).
As to claim 2, modified Zhu discloses the inhaler of claim 1, wherein the silane having one or more reactive silane groups comprises a compound of Formula (I)
X3-m (R1)mSi - Q - Si(R2)k X3-k (I)
wherein Ri and R2 are independently selected from C1-C4 alkyl, X is a hydrolysable group or a hydroxy group, m and k are independently 0, 1, or 2 and Q is a divalent organic linking group (see paragraph [0058] of Zhu).
As to claim 3, modified Zhu discloses the inhaler of claim 2, wherein Q comprises a substituted or unsubstituted C2 to C12 hydrocarbyl chain (paragraph [0059]).
As to claim 4, modified Zhu discloses the inhaler of claim 1, wherein the silane having one or more reactive silane groups comprises a mixture of two or more of 1,2- bis(trialkoxysilyl) ethane, 1,6- bis(trialkoxysilyl) hexane, 1,8- bis(trialkoxysilyl) octane, 1,4- bis(trialkoxysilylethyl)benzene, bis(trialkoxysilyl)itaconate, and 4,4'-bis(trialkoxysilyl)- 1,1'-diphenyl (paragraph [0059] of Zhu).
As to claim 5, modified Zhu discloses the inhaler of claim 1, wherein the perfluoropolyether silane is a compound of Formula (Ia)
Rf[Q1-[C(R)2-Si(Y)3-x(R1a)x]y]z (Ia)
wherein:
Rf is a monovalent or multivalent polyfluoropolyether moiety;
Q1 is an organic divalent or trivalent linking group;
each R is independently hydrogen or a C1-4 alkyl group;
each Y is independently a hydrolysable group;
each Ria is independently a C1-8 alkyl or phenyl group;
xis0 or 1 or 2;
y is 1 or 2; and
z is 1, 2, 3, or 4 (see paragraphs [0063]-[0070], [0092]-[0101] of Zhu).
As to claim 6, modified Zhu discloses the inhaler of claim 5, wherein the compound of Formula (Ia) is a compound of Formula (Ib)
Rf[Q1-[C(R)2-Si(O-)3-x(R1a)x]y]z (Ib)
wherein:
Rf is a monovalent or multivalent polyfluoropolyether segment;
Q1 is an organic divalent or trivalent linking group;
each R is independently hydrogen or a C1-4 alkyl group; and
each R1a is independently a C1-8 alkyl or phenyl group (paragraphs [0063]-[0070],[0092]-[0101] of Zhu).
As to claim 7, modified Zhu discloses the inhaler of claim 5, wherein the compound of Formula (Ia) is a compound of Formula (Ic)
RfQ1v[Q2w-[C(R4)2-Si(X)3-x(R5)x]y]z (Ic)
wherein:
Rf is a polyfluoropolyether moiety;
Q1 is a trivalent linking group;
each Q2 is an independently selected organic divalent or trivalent linking group;
each R4 is independently hydrogen or a C1-4 alkyl group;
each X is independently a hydrolysable or hydroxyl group;
R is a C1-8 alkyl or phenyl group;
v and w are independently 0 or 1, x is 0 or 1 or 2; y is 1 or 2; and z is 2, 3, or 4 (paragraph [0063]-[0070] of Zhu).
As to claim 8, modified Zhu discloses the inhaler of claim 7, wherein each of x, y, and z of Formula (Ic) are 1 (paragraph [0070] of Zhu).
As to claim 9, modified Zhu discloses the inhaler of claim 7, wherein y of Formula (Ic) is 0 (paragraph [0070] of Zhu).
As to claim 10, modified Zhu discloses the inhaler of claim 5, wherein Rf comprises perfluorinated repeating units selected from the group consisting of -(CnF2n)-,-(CF(Z)O)-, -(CF(Z)CnF2n0)-, -(CnF2nCF(Z)O)-, -(CF2CF(Z)O)-, and combinations thereof,
wherein n is an integer from 1 to 6, and
Z is a perfluoroalkyl group, an oxygen-containing perfluoroalkyl group, a perfluoroalkoxy group, or an oxygen-substituted perfluoroalkoxy group, each of which can be linear, branched, or cyclic, and have 1 to 5 carbon atoms and up to 4 oxygen atoms when oxygen-containing or oxygen-substituted and wherein for repeating units including Z the number of carbon atoms in sequence is at most 6 (paragraph [0071]).
As to claim 11, modified Zhu discloses the inhaler of claim 5, wherein n is an integer from 1 to 4, optionally 1 to 3 (paragraph [0071] of Zhu).
As to claim 12, modified Zhu discloses the inhaler of claim 5, wherein Z is a perfluoroalkyl group, an oxygen- containing perfluoroalkyl group, a perfluoroalkoxy group, or an oxygen-substituted perfluoroalkoxy group (paragraph [0071] of Zhu).
As to claim 13, modified Zhu discloses the inhaler of claim 5, wherein Rf is selected from the group consisting of -CF2O(CF2O)m(C2F4O)pCF2-, CF(CF3)O(CF(CF3)CF2O)pCF(CF3) , -CF2O(C2F40)pCF2-, -(CF2)3O(C4FSO)p(CF2)3-,-CF(CF3)-(OCF2CF(CF 3))pO-CtF2t-O(CF(CF3)CF2O)pCF(CF3)-, wherein t is 2, 3 or 4, m is 1 to 50, and p is 3 to 40 (paragraph [0071] of Zhu).
As to claim 14, modified Zhu discloses the inhaler of claim 1, wherein the valve comprises a valve stem and the coating is disposed on at least a portion of the valve stem (paragraph [0075] of Zhu).
As to claim 15, modified Zhu discloses the inhaler of claim 1, wherein the albuterol, one or more pharmaceutically acceptable salts thereof, or one or more pharmaceutically acceptable hydrates of any of the foregoing is albuterol sulfate (paragraph [0014] of Zhu).
As to claim 16, modified Zhu discloses the inhaler of claim 1, wherein the free albuterol is present in a concentration of 2.5 mg/mL or greater (taking the molecular weight of albuterol sulfate (576.7) and the molecular weight of free base albuterol (239.3), Zhu’s concentration range of 4-11 mg/mL of albuterol sulfate can be converted into a free base albuterol concentration range of 1.7 mg/mL to 4.6 mg/mL, which overlaps the claimed range. Therefore, a prima facie case of obviousness exists (see MPEP 2144.05 I).
As to claim 17, modified Zhu discloses the inhaler of claim 1, wherein the valve volume is no more than 35 µL, (paragraph [0033] of Zhu, last four lines – 20-35 µL).
As to claim 18, modified Zhu discloses the inhaler of claim 1, further comprising an actuator that, when actuated, releases about 70 micrograms (µg) to about 140 µg, (paragraph [0039] of Zhu, 55-75 µL overlaps the claimed range. Thus, a prima facie case of obviousness exists, see MPEP 2144.05 (I)).
As to claim 19, modified Zhu discloses the inhaler of claim 1, wherein the valve is a metered valve (paragraph [0033] of Zhu).
As to claim 20, modified Zhu discloses the inhaler of claim 1, further comprising a dose counter (paragraph [0042] of Zhu).
As to claim 21, modified Zhu discloses the inhaler of claim 1, wherein the propellant is HFC-134a (paragraphs [0021], [0037],[0164] of Zhu).
As to claim 22, modified Zhu discloses a method of activating the inhaler of claim 1, the method comprising actuating the inhaler of clam 1 to release the albuterol, one or more pharmaceutically acceptable salts thereof, or one or more pharmaceutically acceptable hydrates from the inhaler (paragraph [0036] of Zhu).
Response to Arguments
Applicant’s arguments, see pages 7-9 of the remarks, filed February 2, 2026, with respect to the rejection(s) of claims 1-22 under 35 U.S.C. § 103 as being obvious over Zhu (US 2018/0071231) in view of Deshmukh (US 2007/0276048) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made under 35 U.S.C. § 103 as being obvious over Zhu (US 2018/0071231) alone.
As noted in the above rejection of claim 1, Zhu discloses a concentration of albuterol sulfate in a range of 4-11 mg/mL (paragraph [0017]) and further discloses that the concentration of albuterol can be calculated from this concentration by comparing the molecular weight of albuterol and the molecular weight of the albuterol sulfate (paragraph [0011]). Thus, after performing such calculation, the concentration of free albuterol in Zhu’s formulation equates to about 1.7 mg/mL to about 4.6 mg/mL, which overlaps the claimed range of 2 mg/mL or greater. Therefore, a prima facie case of obviousness exists considering the disclosure of Zhu alone.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VALERIE L WOODWARD whose telephone number is (571)270-1479. The examiner can normally be reached on Monday - Friday 8:30 am - 4:30 pm.
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/VALERIE L WOODWARD/Primary Examiner, Art Unit 3785