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 .
Receipt is acknowledged of Amendment, Remarks and Election on 08/14/25. Claims 1-7, 9 and 23 have been canceled, claims 8, 10, 20 and 24-25 have been amended and no new claims have been added. Accordingly, claims 8, 10-22 and 24-25 are pending and under examination on the merit.
Election/Restrictions
Applicant's election with traverse of Group III (claims 8, 9 and 14) in the reply filed on 08/14/25 is acknowledged. The traversal is on the grounds that claims 20-22 and 24-25 have been revised to depend on claim 14, included in Group III and that Groups III and IV have unity of invention by reciting the technical feature of how the product is mixed and formulated, which is not disclosed by the prior art, WO 202031119, as recited in the action. Applicant argues that “The document alleged to disclose the technical feature of the previously submitted claims merely discloses adding all of the ingredients together and mixing them. It does not disclose the method recited by claim 8, nor does it disclose or suggest conditioning the mixture because the invention disclosed in WO 2020/31119 is concerned entirely with monitoring the mixing of powder components using Raman Spectrometry. Applicant therefore respectfully traverses the restriction requirement, and contends that Groups III and IV have unity of invention and should be examined together” (See Remarks pages 6-7).
This is not found persuasive because WO ‘119 teaches the method of claim 8 and the product of claim 14, and as such meets the requirement of the special technical feature.
However, the withdrawn claims may be considered for rejoinder at the time of allowance.
The requirement is still deemed proper and is therefore made FINAL.
Claim 9 has been canceled. Accordingly, claims 8 and 14 are under examination and claims 10-13, 15-22 and 24-25 are withdrawn.
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.
Claim 14 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shah et al (WO 2020031119).
Shah et al teach a dry powder composition for inhalation comprising at least two active pharmaceutical ingredients and an excipient, and wherein the method comprises blending the said active agents and the excipient and determining the blend homogeneity (See abstract).
The said dry powder composition may comprise fluticasone propionate, albuterol sulfate and α-lactose monohydrate (See [057], [085], [0100] and [0101]).
NOTE: Claim 14 is a product-by-process claim. According to MPEP § 2113 [R-1], product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps. Therefore, claim 14 is taught by the Shah et al reference.
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 8 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Shah et al (WO 2020031119).
Shah et al teach a dry powder composition for inhalation comprising at least two active pharmaceutical ingredients and an excipient, and wherein the method comprises blending the said active agents and the excipient and determining the blend homogeneity (See abstract).
The said dry powder composition may comprise fluticasone propionate, albuterol sulfate and α-lactose monohydrate (See [057], [085], [0100] and [0101]).
It would have been prima facie obvious to a person of ordinary skilled in the art at the time the invention was made to have followed the teachings of Shah et al to arrive at the instant invention. One of ordinary skill in the art would have been motivated to follow Shah et al’s method to make a blend of two or more active agents and an excipient to make an inhalable dry powder composition because Shah et al teach that the method results in effective and uniform blend of the active agents and an excipient.
Shah et al lack a specific disclosure on the step of preparing a mixture of fluticasone propionate and α-lactose monohydrate, a mixture of albuterol sulfate and α-lactose monohydrate before blending the two mixtures. However, the obtained dry powder formulation would have the same components and as such it would have been obvious to one of ordinary skill in the art to either prepare each mix separately or mix them contents together. That is, either order of preparation would have led one of ordinary skill in the art to the same product.
In this regard, MPEP states that “Unless Applicant demonstrates the criticality of the order of addition and that the prior art is not the same product as the instant application, changes in sequence of adding ingredients has been rendered to be prima facie obvious, See MPEP § 2144.04 [R-1] In re Gibson, 39 F.2d 975, 5 USPQ 230 (CCPA 1930) (Selection of any order of mixing ingredients is prima facie obvious).
Claims 8 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Shah et al (WO 2020031119) in view of Tummala et al (US 20050032235).
Shah et al teach a dry powder composition for inhalation comprising at least two active pharmaceutical ingredients and an excipient, and wherein the method comprises blending the said active agents and the excipient and determining the blend homogeneity (See abstract).
The said dry powder composition may comprise fluticasone propionate, albuterol sulfate and α-lactose monohydrate (See [057], [085], [0100] and [0101]).
Shah et al lack a specific disclosure on the two active agents being mixed with lactose separately before being blended together. This method step would have been obvious in view of the teachings of Tummala et al.
Tummala et al teach a method of monitoring the blending of at least two blendable components to yield a mixture (See abstract).
It is disclosed that the said components may be in the form of powders and the mixture is typically homogenous in that proper amounts or concentrations of the pharmaceutical active must be uniformly distributed throughout the pharmaceutical composition for administration to a patient (See [0003]).
It is important to ensure that the concentration of the non-active components (e.g., excipients) within the mixture is uniform since inconsistency of the non-active component can also adversely affect the quality and effectiveness of the final pharmaceutical composition. The said pharmaceutical composition may comprise microcrystalline cellulose and/or lactose monohydrate (See [0004] and [0047]).
The term “components” generally refers to discrete blendable parts of a mixture which may be selected from any blendable materials, including powders, particulates, etc, (See [0038]).
Tummala et al teach a method of monitoring the blending of at least two blendable components with at least two of the blendable components having different peak spectra, comprising blending the at least two components in a vessel to form a mixture and optionally continuing to blend the at least two components and repeating steps until a predetermined match of the ratios is obtained (See [0015], [0021] and claim 10).
It would have been prima facie obvious to a person of ordinary skilled in the art at the time the invention was made to have combined the teachings of Tummala et al with that of Shah et al to arrive at the instant invention. It would have been obvious to do so because Shah et al disclose the dry powder formulations for delivery to the respiratory system comprising fluticasone propionate, albuterol sulfate and α-lactose monohydrate and disclose the most suitable particle size distribution for inhalation. Shah et al disclose blending the said active agents and the excipient and determining the blend homogeneity. Tummala et al also teach blending of at least two blendable components with at least two of the blendable components having different peak spectra, comprising blending the at least two components in a vessel to form a mixture and optionally continuing to blend the at least two components and repeating steps until a predetermined match of the ratios is obtained. Thus, it would have been obvious to take guidance from Tummala et al and modify Shah et al’s method of making a dry powder composition by blending the components and arrive at the claimed method of claim 8, wherein two mixtures of an active agent and an excipient are blended together, wherein the two active agents have different peak spectra.
In other words, the claims would have been obvious because the technique for improving a particular formulation was part of the ordinary capabilities of a person of ordinary skill in the art, in view of the teaching of the technique for improvement in other situations.
Additionally, the courts have held that “A reference is good not only for what it teaches by direct anticipation but also for what one of ordinary skill in the art might reasonably infer from the teachings. (In re Opprecht 12 USPQ 2d 1235, 1236 (Fed Cir. 1989); In re Bode 193 USPQ 12 (CCPA) 1976).
Claims 8 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Roche et al (US 20090291146) in view of Tummala et al (US 20050032235).
Roche et al teach a dry powder formulation and inhaler comprising a containing one or more medicament and lactose particles (See abstract and [0006]).
It is disclosed that the said lactose particles consist essentially of α-lactose monohydrate (See [0016]).
Disclosed are dry powder pharmaceutical formulation suitable for inhalation comprising medicaments, including fluticasone propionate and salbutamol sulphate (i.e. albuterol sulfate) (See [0034], [0037] and claims 22 and 34).
Roche et al dry powder formulations for topical delivery to the lung by inhalation may, for example, be presented in capsules and cartridges for use in an inhaler or insufflator. Powder blend formulations generally contain a powder mix for inhalation comprising a suitable powder base which includes lactose and, optionally, at least one additional excipient (e.g., carrier, diluent, etc.) (See [0043]).
Roche et al claim a process comprising combining lactose particles with at least one medicament to form a pharmaceutical formulation, wherein the pharmaceutical formulation is a dry powder pharmaceutical formulation suitable for inhalation (See claims 19-22).
Roche et al lack a specific disclosure on the two active agents being mixed with lactose separately before being blended together. This method step would have been obvious in view of the teachings of Tummala et al.
Tummala et al teach a method of monitoring the blending of at least two blendable components to yield a mixture (See abstract).
It is disclosed that the said components may be in the form of powders and the mixture is typically homogenous in that proper amounts or concentrations of the pharmaceutical active must be uniformly distributed throughout the pharmaceutical composition for administration to a patient (See [0003]).
It is important to ensure that the concentration of the non-active components (e.g., excipients) within the mixture is uniform since inconsistency of the non-active component can also adversely affect the quality and effectiveness of the final pharmaceutical composition. The said pharmaceutical composition may comprise microcrystalline cellulose and/or lactose monohydrate (See [0004] and [0047]).
The term “components” generally refers to discrete blendable parts of a mixture which may be selected from any blendable materials, including powders, particulates, etc, (See [0038]).
Tummala et al teach a method of monitoring the blending of at least two blendable components with at least two of the blendable components having different peak spectra, comprising blending the at least two components in a vessel to form a mixture and optionally continuing to blend the at least two components and repeating steps until a predetermined match of the ratios is obtained (See [0015], [0021] and claim 10).
It would have been prima facie obvious to a person of ordinary skilled in the art at the time the invention was made to have combined the teachings of Tummala et al with that of Roche et al to arrive at the instant invention. It would have been obvious to do so because Roche et al disclose the dry powder formulations for delivery to the respiratory system comprising fluticasone propionate, albuterol sulfate and α-lactose monohydrate and disclose the most suitable particle size distribution for inhalation.
Roche et al disclose blending the said active agents and the excipient and determining the blend homogeneity. Tummala et al also teach blending of at least two blendable components with at least two of the blendable components having different peak spectra, comprising blending the at least two components in a vessel to form a mixture and optionally continuing to blend the at least two components and repeating steps until a predetermined match of the ratios is obtained. Thus, it would have been obvious to take guidance from Tummala et al and modify Roche et al’s method of making a dry powder composition by blending the components and arrive at the claimed method of claim 8, wherein two mixtures of an active agent and an excipient are blended together, wherein the two active agents have different peak spectra.
In other words, the claims would have been obvious because the technique for improving a particular formulation was part of the ordinary capabilities of a person of ordinary skill in the art, in view of the teaching of the technique for improvement in other situations.
Additionally, the courts have held that “A reference is good not only for what it teaches by direct anticipation but also for what one of ordinary skill in the art might reasonably infer from the teachings. (In re Opprecht 12 USPQ 2d 1235, 1236 (Fed Cir. 1989); In re Bode 193 USPQ 12 (CCPA) 1976).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 8 and 14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 6 of U.S. Patent No. 11,638,710. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by the reference claims. The said instant claims are generic to all that is recited in reference claims. That is, the reference claims fall entirely within the scope of the instant claims.
Instant claim 8 is drawn to a method of preparing a dry powder inhalable formulation comprising (i) preparing a mixture of fluticasone propionate and α-lactose monohydrate to form a first blend; (ii) preparing a mixture of albuterol sulfate and α-lactose monohydrate to form a second blend; and (iii) mixing the first blend and the second blend to form the formulation.
Reference claim 6 is drawn to a method of preparing a mixture of fluticasone propionate and α-lactose monohydrate to form a first blend; preparing a mixture of albuterol sulfate and α-lactose monohydrate to form a second blend; and (iii) mixing the first blend and the second blend to form the formulation.
The difference is that reference claim 6 depends on reference claim 5, which states that the said formulation has an extended in-use shelf life. This limitation is a property of the claimed formulation and does not materially change the scope of the claimed method or dry powder. Accordingly, examined claim 8 is the same as reference claim 6.
Examined claim 14 is drawn to a product obtainable by the process of claim 8. This is a product-by-process claim. Reference claim 1 is drawn to a dry powder inhalable formulation consisting of fluticasone propionate, albuterol sulfate and α-lactose monohydrate, wherein the formulation has an extended in-use shelf life when compared to a composition consisting of fluticasone propionate and α-lactose monohydrate.
The differences are that the reference claim 1 recites the closed transitional phrase of “consisting of” while the examined claim 14 does not. Also reference claim 1 states that the said formulation has an extended in-use shelf life. This limitation is a property of the claimed formulation and does not materially change the scope of the claimed method or dry powder. Accordingly, examined claim 14 is the same as reference claim 1.
Thus, it is clear from the above recitations that the two sets of claims are essentially drawn to the same methods and same formulation. As such the instant claims are anticipated by the reference claims.
Claims 8 and 14 are rejected. Claims 10-13, 15-22 and 24-25 are withdrawn.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mina Haghighatian whose telephone number is (571)272-0615. The examiner can normally be reached M-F, 7-5 EST.
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/Mina Haghighatian/
Mina Haghighatian
Primary Examiner
Art Unit 1616