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 .
Receipt is acknowledged of Amendments and Remarks filed on 12/15/25. Claims 1 and 21 have been amended, new claims 34-36 has been added and claims 24-33 have been cancelled. Accordingly, claims 1-5, 7, 9, 21-23 and 34-36 are pending and under examination on the merits.
Rejections and/or objections not reiterated from the previous Office Action are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant 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.
Claim 35 is 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 35 is indefinite for improper broadening of the parent claim. Claim 35 depends on claim 21 which recites that “wherein the chemically stable pharmaceutical composition consists entirely of (i), (ii) and (iii)”. However, claim 35 recites that the composition comprises less than 500 ppm of water, which is excluded by parent claim 21’s language.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 36 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 36 depends on claim 21 which already excludes water. Therefore, stating that the composition is water-free fails to further limit the parent claim 21. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 1-5, 7, 9, 21-23 and 34-36 are rejected under 35 U.S.C. 103 as being unpatentable over Berry et al (6,068,832) in combination with Corr et al (WO 2012156711) and Backstrom et al (6,932,962) as evidenced by DAIKIN HFC-152a product information or UNFCCC (Global Warming Potentials).
Berry et al teach suspension aerosol formulations which exhibit stable particle sizes, containing micronized mometasone furoate, about 1 to about 10 wt% ethanol and 1,1,1,2,3,3,3-Heptafluoropropane as the propellant. A surfactant, such as oleic acid, can also be included. These formulations are suitable for use in metered dose inhalers (See abstract and claim 1).
Berry et al disclose examples of formulations which may comprise from 0.028 to 0.44% of mometasone furoate, from 1.7 to 4.9% ethanol, from 97-98% of propellant and formulations that have 0% surfactant (See Example 1 in Col. 4).
Berry et al further teach that “The formulation of the present invention does not require a surfactant for maintenance of ready dispersability (such as by moderate agitation immediately prior to use), as the drug forms loose flocculates in the propellant and does not exhibit a tendency to settle or compact. Upon undisturbed storage, the drug particles merely remain in their flocculated state (See Col. 3, lines 59-65).
Berry et al’s formulations do not comprise water, perforated microstructures, acid stabilizers or surfactants (See Example 1 and entire document).
Berry et al lack a specific disclosure on the propellant being 1,1-difluroethane. This is known in the art as shown by Corr et al and evidenced by DAIKIN HFC-152a or UNFCCC (Global Warming Potentials).
Corr et al teach a pharmaceutical composition comprising a drug, 1 ,1-difluoroethane (R-152a) propellant and ethanol that is suitable for delivering the drug, especially from a pressurised aerosol container using a metered dose inhaler (MDI). The drug formulation will comprise a propellant, in which the drug is dissolved, suspended or dispersed, and may contain other materials such as co- solvents, surfactants and preservatives (See Page 1, lines 1-3 and 18-20).
Disclosed is a sealed container that contains the said pharmaceutical solution which is a pressurized aerosol container for use with a metered dose inhaler (MDI) (See claims 20-22).
Corr et al disclose that there is a need for an MDI aerosol formulation that has a reduced GWP in comparison with R-134a and R-227ea, that has acceptable flammability and toxicity performance and which forms stable suspensions or solutions with a range of pharmaceutical actives and with reduced irritancy (See page 3, line 33-34 to page 4, line 2).
Thus, Corr et al disclose the use of a propellant consisting essentially of and preferably consisting entirely of 1 ,1- difluoroethane (R-152a) in a pharmaceutical composition comprising a drug, the propellant and ethanol in order to reduce the amount of ethanol required for dissolving the drug in the pharmaceutical composition compared to the amount that would be needed if 1 ,1 ,1 ,2-tetrafluoroethane (R-134a) is used as the propellant (See page 4, lines 4-10).
It is disclosed that “By the term "consists essentially of” we mean that at least 90 wt %, preferably at least 95 wt %, more preferably at least 98 wt % and especially at least 99 wt % of the propellant component is 1 ,1-difluoroethane
(R-152a)” (See page 5, lines 13-18).
Corr et al, in a preferred embodiment, provide a pharmaceutical solution for a medication delivery apparatus, especially a metered dose inhaler, which consists essentially of: (a) a liquefied propellant component consisting essentially of and preferably consisting entirely of 1 ,1-difluoroethane (R-152a); (b) ethanol; and (c) a drug component dissolved in the propellant/ethanol mixture consisting of at least one drug selected from the group consisting of beclomethasone dipropionate (BDP) and fluticasone propionate (FP) (See page 7).
The said pharmaceutical solutions are for use in medicine for treating a patient suffering from a respiratory disorder and especially asthma or a chronic obstructive pulmonary disease. (See page 8, lines 1-10).
Corr et al further disclose that the FPF (fine particle fraction) of the emitted dose of the said formulation comprising HFA 152a and ethanol is 53.7% or 46.3% (See pages 15-16 and Tables 4-5).
Backstrom et al teach hydrofluoroalkane (HFA) propellants for example 1,1,1,2-tetrafluoroethane (P134a), 1,1,1,2,3,3,3-heptafluoropropane (P227) and 1,1-difluoroethane (P152a) are today considered to be the most promising new propellants. Not only are they environmentally acceptable, but they also have low toxicity and vapor pressures suitable for use in aerosols (See col. 1, lines 40-46 and col. 2, lines 39-42).
Disclosed is a pharmaceutical aerosol formulation wherein the formulation comprises a propellant selected from the group consisting of 1,1,1,2-tetrafluoroethane (P134a), 1,1,1,2,3,3,3-heptafluoropropane (P227), or 1,1-difluoroethane (P152a). Also disclosed and claimed is a metered dose inhaler comprising the formulation comprising 1,1-difluoroethane (P152a) (See claims 4 and 40).
The said formulations for inhalation may also comprise a surfactant selected from a C8 -C16 fatty acid or salt thereof, a bile salt, a phospholipid or an alkyl saccharide. In addition to medicament, propellant and surfactant, a small amount of ethanol (normally up to 5% but possibly up to 20%, by weight) may be included in the said formulations (See col. 2, lines 3-15 and 47-54).
Suitable medicaments for the said formulations include mometasone and formoterol or a salt thereof (See col. 2, lines 54-67 and claims 12, 29 and 48). One disclosed salt of formoterol is fumarate (See Example 1).
The active agents can be micronized and in a suspension form. Micronised active agents mixed with excipients and propellants are added to a plastic-coated glass bottle and sealed with a metering valve (See at least Examples, 1-4 and claims 1 and 37-39).
Backstrom et al disclose that “Formulations of various medicaments in P134a and/or P227 with different surfactants were prepared in order to assess the quality of the suspensions formed. In the following examples the quality of the suspension is rated as “acceptable” or “good”. An acceptable suspension is characterised by one or more of slow settling or separation, ready re-dispersion, little flocculation, and absence of crystallisation or morphology changes, such that the dispersion is sufficiently stable to give a uniform dosing. A good dispersion is even more stable”. Examples 1-8 resulted in good suspension (See Col. 4, line 12 to Col. 5, line 4).
Evidences:
DAIKIN HFC-152a product information discloses that HFC-152a has a lower global warming potential compared to other fluorocarbons. With its physical properties resembling those of HFC-134a, is used as an environment-friendly substitute for HFC-134a as aerosol propellant.
UNFCCC (Global Warming Potentials) provides a list of all gases with their global warming potential and atmospheric lifetime. The list shows that HFC-152a has an atmospheric lifetime of 1.5 years and a 20 years GWP of 460, while the same values are 14.6 and 3400 for HFC-134a and 36.5 and 4300 for HFC-227a.
It would have been obvious to a person of ordinary skilled in the art at the time the invention was made to have combined the teachings of Corr et al and Backstrom et al with that of Berry et al and as evidenced by DAIKIN HFC-152a product information and/or UNFCCC (Global Warming Potentials) to arrive at the instant invention. It would have been obvious to do so because Berry et al teach formulations comprising mometasone furoate, ethanol and an HFA propellant and without a surfactant, delivered by a metered dose inhaler for inhalation. Corr et al teach stable suspension or solution inhalation and a metered dose inhaler comprising the said formulation comprising one or more drugs for inhalation, ethanol and a propellant. Corr et al disclose that 1,1-difluoroethane (HFA 152a) is a more suitable propellant than HFA-134 because it has lower GWP and is environmentally friendly choice for aerosolization of formulations. Corr et al also disclose that the propellant is consisting essentially of and preferably consisting entirely of 1,1- difluoroethane (R-152a). Backstrom et al also discloses stable suspension formulations comprising one or more active agents including mometasone or a salt thereof and an HFA propellant including HFA 134, HFA 227 or HFA 152a. Backstrom et al discloses examples of formulations comprising various active agents in suspension form and comprising HFA 134 or HFA 227 wherein the suspension stability is “good”, indicating stable suspensions. That is Backstrom et al while not exemplifying a suspension comprising HFA 152a, considers all three propellants alternatively usable species. As such one of ordinary skill in the art having possession of the teachings of the references would have been motivated to have substituted HFc-227 propellants of Berry et al because it is highly recommended by Corr et al, disclosed by Backstrom et al and also by DAIKIN HFC-152a product information and/or UNFCCC (Global Warming Potentials), with a reasonable expectation of success.
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.
While the references do not expressly disclose the level of impurity from degradation in storage, it is considered that the same formulations stored in the same device would have the same properties and characteristics.
The claimed limitation of drug particles in the suspension taking at least 2 minutes to settle following complete dispersion in the R-152a containing propellant, is also expected to be present as the prior art leads one of ordinary to the same composition.
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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-5, 7, 9, 21-23 and 34-36 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 6-10 and 12 of U.S. Patent No. 10,258,568 in view of Mueller-Walz (US 20070256685) and Keller et al (6,585,958).
The obviousness Double Patenting rejection is appropriate because while the conflicting claims are not identical, they are not patentably distinct from the reference claims. The instant claims would have been obvious over the reference claims in view of Muller-Walz and Keller et al.
Examined claims are drawn to a composition in a suspension form comprising a mometasone compound, ethanol and a propellant comprising 1,1-difluoroethane (R-152a).
Reference claims are drawn to a pharmaceutical composition in a solution form comprising: a) beclomethasone dipropionate (BDP) and/or fluticasone propionate (FP); b) propellant 1,1-difluoroethane (R-152a); and c) a first amount of ethanol.
Specifically, the first difference is that the examined claims require mometasone or mometasone furoate, while the reference claims require beclomethasone dipropionate and/or fluticasone. However, it would have been obvious to one of ordinary skill in the art to have selected different active agents for the same formulations as taught by Mueller–Walz which teach inhalable formulations comprising a propellant such as HFA-152 and wherein the active agent may be mometasone furoate, formoterol fumarate di-hydrate, beclomethasone dipropionate, fluticasone propionate, etc. As such one of ordinary skill in the art would have been more than motivated to have selected any active agent or combinations thereof for their known benefits and excepted effectiveness. The factual underpinning is that different active agents are considered alternatively usable species and as such one of ordinary skill in the art is more than capable of substituting one species / active agent for another with a reasonable expectation of success.
In this regard, the courts have held that “It is generally considered to be prima facie obvious to substitute components which are taught by the prior art to be well known and useful for the same purpose in order to form a composition that is to be used for an identical purpose. The motivation for substituting them flows from their having been used in the prior art, and from their being recognized in the prior art as useful for the same purpose. As shown by the recited teachings, instant claims are no more than the substituting conventional components of pharmaceutical active agents, and particularly steroids. It therefore follows that the instant claims define prima facie obvious subject matter. Cf. In re Ruff, 256 F.2d 590, 118 USPQ 340 (CCPA 1958).
The other difference is that examined claims are drawn to formulation is suspension form while the reference claims are to a solution form. However, one of ordinary skill in the art would have been motivated to prepare the formulations as suspension or solutions because as taught by Keller et al, the same compositions can be made into a suspension or solution.
Claims 1-5, 7, 9, 21-23 and 34-36 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8, 10-13 of U.S. Patent No. 10,258,569 in view of Mueller-Walz (US 20070256685) and Keller et al (6,585,958).
The obviousness Double Patenting rejection is appropriate because while the conflicting claims are not identical, they are not patentably distinct from the reference claims. The instant claims would have been obvious over the reference claims in view of Mueller-Walz and Keller et al.
Examined claims are drawn to a composition in suspension form comprising a mometasone compound, ethanol and a propellant comprising 1,1-difluoroethane (R-152a).
Reference claims are drawn to a pharmaceutical solution comprising: a) a liquefied propellant comprising 1,1-difluoroethane (R-152a); b) 1-20 wt% of ethanol, and c) beclomethasone dipropionate (BDP) and fluticasone propionate (FP).
Specifically, the first difference is that the examined claims require mometasone or mometasone furoate, while the reference claims require beclomethasone dipropionate and/or fluticasone. However, it would have been obvious to one of ordinary skill in the art to have selected different active agents for the same formulations as taught by Mueller–Walz which teach inhalable formulations comprising a propellant such as HFA-152 and wherein the active agent may be mometasone furoate, formoterol fumarate di-hydrate, beclomethasone dipropionate, fluticasone propionate, etc. As such one of ordinary skill in the art would have been more than motivated to have selected any active agent or combinations thereof for their known benefits and excepted effectiveness. The factual underpinning is that different active agents are considered alternatively usable species and as such one of ordinary skill in the art is more than capable of substituting one species / active agent for another with a reasonable expectation of success.
In this regard, the courts have held that “It is generally considered to be prima facie obvious to substitute components which are taught by the prior art to be well known and useful for the same purpose in order to form a composition that is to be used for an identical purpose. The motivation for substituting them flows from their having been used in the prior art, and from their being recognized in the prior art as useful for the same purpose. As shown by the recited teachings, instant claims are no more than the substituting conventional components of pharmaceutical active agents, and particularly steroids. It therefore follows that the instant claims define prima facie obvious subject matter. Cf. In re Ruff, 256 F.2d 590, 118 USPQ 340 (CCPA 1958).
The other difference is that examined claims are drawn to formulation is suspension form while the reference claims are to a solution form. However, one of ordinary skill in the art would have been motivated to prepare the formulations as suspension or solutions because as taught by Keller et al, the same compositions can be made into a suspension or solution.
Claims 1-5, 7, 9, 21-23 and 34-36 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 10-19 and 21 of U.S. Patent No. 10,668,018 in view of Mueller-Walz (US 20070256685) and Keller et al (6,585,958).
The obviousness Double Patenting rejection is appropriate because while the conflicting claims are not identical, they are not patentably distinct from the reference claims. The instant claims would have been obvious over the reference claims in view of Mueller-Walz and Keller et al.
Examined claims are drawn to a composition in a suspension form comprising a mometasone compound, ethanol and a propellant comprising 1,1-difluoroethane (R-152a).
Reference claims are drawn to a composition comprising at least one corticosteroid; a propellant comprising R-152a and first amount of ethanol and a second amount of ethanol, wherein the composition is a solution.
Specifically, the differences are that the examined claims require mometasone while the reference claims require a drug comprising at least one corticosteroid. This is however obvious in view of Mueller-Walz which teach inhalable formulations comprising a propellant and wherein the active agent may be a corticosteroid such as mometasone furoate. As such one of ordinary skill in the art would have been more than motivated to have selected any active agent for their known benefits and excepted effectiveness. The factual underpinning is that different active agents are considered alternatively usable species and as such one of ordinary skill in the art is more than capable of substituting one species / active agent for another with a reasonable expectation of success.
In this regard, the courts have held that “It is generally considered to be prima facie obvious to substitute components which are taught by the prior art to be well known and useful for the same purpose in order to form a composition that is to be used for an identical purpose. The motivation for substituting them flows from their having been used in the prior art, and from their being recognized in the prior art as useful for the same purpose. As shown by the recited teachings, instant claims are no more than the substituting conventional components of pharmaceutical active agents, and particularly steroids. It therefore follows that the instant claims define prima facie obvious subject matter. Cf. In re Ruff, 256 F.2d 590, 118 USPQ 340 (CCPA 1958).
The other difference is that examined claims are drawn to formulation is suspension form while the reference claims are to a solution form. However, one of ordinary skill in the art would have been motivated to prepare the formulations as suspension or solutions because as taught by Keller et al, the same compositions can be made into a suspension or solution.
Claims 1-5, 7, 9, 21-23 and 34-36 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 7-9, 11-16, 29-31, 34-40 of U.S. Patent No. 10,792,256 in view of Finch et al (US 20140248357) and Mueller-Walz (US 20070256685).
The obviousness Double Patenting rejection is appropriate because while the conflicting claims are not identical, they are not patentably distinct from the reference claims. The instant claims would have been obvious over the reference claims in view of Finch et al and Mueller-Walz.
Examined claims are drawn to a composition in a suspension form comprising a mometasone compound, ethanol and a propellant comprising 1,1-difluoroethane (R-152a).
Reference claims are drawn to a composition comprising at least one salmeterol compound, optionally at least on long-acting muscarinic antagonist, at least one corticosteroid and a propellant comprising of R-152a and ethanol. The formulations may be in a suspension form.
Specifically, the difference is that the examined claims require mometasone while the reference claims require at least one salmeterol compound, optionally at least one LAMA and at least one corticosteroid. The modifications in the type and number of active agents in the formulation, however, would have been obvious to one of ordinary skill in the art in view of Finch et al and Mueller-Walz which teach inhalable formulations comprising HFA 152a and wherein the active agent may be a corticosteroid such as mometasone furoate, fluticasone and other active agents such as salmeterol, formoterol fumarate dihydrate, etc, and mixtures thereof. As such one of ordinary skill in the art would have been more than motivated to have selected any active agent or combinations thereof for their known benefits and excepted effectiveness. The factual underpinning is that different active agents are considered alternatively usable species and as such one of ordinary skill in the art is more than capable of substituting one species / active agent for another with a reasonable expectation of success.
In this regard, the courts have held that “It is generally considered to be prima facie obvious to substitute components which are taught by the prior art to be well known and useful for the same purpose in order to form a composition that is to be used for an identical purpose. The motivation for substituting them flows from their having been used in the prior art, and from their being recognized in the prior art as useful for the same purpose. As shown by the recited teachings, instant claims are no more than the substituting conventional components of pharmaceutical active agents, and particularly steroids. It therefore follows that the instant claims define prima facie obvious subject matter. Cf. In re Ruff, 256 F.2d 590, 118 USPQ 340 (CCPA 1958).
Claims 1-5, 7, 9, 21-23 and 34-36 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent No. 11,690,823; 11,179,366; 11,642,330; 11,077,076; 11,311,502; 11,103,480; 11,260,052; 11,559,507; 11,559,505; 10,792,256; 10,888,546 in view of Finch et al (US 20140248357), Mueller-Walz (US 20070256685) and/or Keller et al (6,585,958).
The obviousness Double Patenting rejection is appropriate because while the conflicting claims are not identical, they are not patentably distinct from the reference claims. The instant claims would have been obvious over the reference claims in view of Finch et al, Mueller-Walz and or Keller et al.
Examined claims are drawn to a composition in a suspension form comprising a mometasone compound, ethanol and a propellant comprising 1,1-difluoroethane (R-152a).
Reference claims are drawn to a composition comprising at least one active agent, propellant R-152a and ethanol. The compositions may be in a suspension or solution form.
Specifically, the difference is that the reference claims require active agents including corticosteroids such as mometasone, formoterol, glycopyrrolate, salmeterol, etc, or any solvate thereof, while examined claims require mometasone or mometasone furoate. This however is obvious in view of Finch et al and Mueller-Walz, as stated above. The references teach that any given formulation may comprise one or more active agents selected from a group of respiratory effective agents including corticosteroids, bronchodilators, etc. Thus, based on the disclosure in the prior art, one of ordinary skill in the art is more than motivated to select different active agents for a dosage form with a reasonable expectation of success.
Also as taught by Keller et al, the disclosed active agents are alternatively usable species in compositions treating respiratory diseases and specially in inhalation formulations. Keller et al also makes the same formulations in either solutions or suspensions.
Furthermore, Keller et al disclose that alternatively usable propellants include HFA 134, HFA 227, HFA 152a, etc.
The factual underpinning is that different active agents are considered alternatively usable species and as such one of ordinary skill in the art is more than capable of substituting one species / active agent for another with a reasonable expectation of success.
In this regard, the courts have held that “It is generally considered to be prima facie obvious to substitute components which are taught by the prior art to be well known and useful for the same purpose in order to form a composition that is to be used for an identical purpose. The motivation for substituting them flows from their having been used in the prior art, and from their being recognized in the prior art as useful for the same purpose. As shown by the recited teachings, instant claims are no more than the substituting conventional components of pharmaceutical active agents, and particularly steroids. It therefore follows that the instant claims define prima facie obvious subject matter. Cf. In re Ruff, 256 F.2d 590, 118 USPQ 340 (CCPA 1958).
As the number of patents applied under obviousness type double patenting is very large, they are rejected collectively and based on similar analysis as stated above.
Claims 1-5, 7, 9, 21-23 and 34-36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 and 15-17 of copending Application No. 17/969,250 (US 20230051849) as evidenced by Mueller-Walz (US 20070256685).
The obviousness Double Patenting rejection is appropriate because while the conflicting claims are not identical, they are not patentably distinct from the reference claims. The instant claims would have been obvious over the reference claims in view of Mueller-Walz.
Examined claims are drawn to a composition comprising at least a mometasone compound, ethanol and a propellant comprising 1,1-difluoroethane (R-152a).
Reference claims are drawn to a pharmaceutical composition comprising one mometasone compound, formoterol fumarate dihydrate, ethanol and a propellant component comprising 1,1-difluoroethane (R-152a).
Specifically, the difference is in that the drug component in the examined claims is a mometasone compound, while the reference claims recite a combination of mometasone and formoterol. This however would have been obvious to one of ordinary skill in the art as both drug components are known to be incorporated in formulations individually and in combination as evidenced by the references of record including Mueller-Walz. As such one of ordinary skill in the art would have been more than motivated to have selected the claimed drug components or combinations thereof for their known benefits and excepted effectiveness. The factual underpinning is that different active agents are considered alternatively usable species and as such one of ordinary skill in the art is more than capable of substituting one species / active agent for another with a reasonable expectation of success.
In this regard, the courts have held that “It is generally considered to be prima facie obvious to substitute components which are taught by the prior art to be well known and useful for the same purpose in order to form a composition that is to be used for an identical purpose. The motivation for substituting them flows from their having been used in the prior art, and from their being recognized in the prior art as useful for the same purpose. As shown by the recited teachings, instant claims are no more than the substituting conventional components of pharmaceutical active agents, and particularly steroids. It therefore follows that the instant claims define prima facie obvious subject matter. Cf. In re Ruff, 256 F.2d 590, 118 USPQ 340 (CCPA 1958).
This is a provisional nonstatutory double patenting rejection.
Claims 1-5, 7, 9, 21-23 and 34-36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 and 21-23 of copending Application No. 17/944,666 (US 20230029174).
The obviousness Double Patenting rejection is appropriate because while the conflicting claims are not identical, they are not patentably distinct from the reference claims. The instant claims would have been obvious over the reference claims in view of Mueller-Walz.
Examined claims are drawn to a composition in a suspension form comprising a mometasone compound, ethanol and a propellant comprising 1,1-difluoroethane (R-152a).
Reference claims are drawn to a composition comprising a drug component consisting of mometasone and formoterol, ethanol and a propellant comprising R-152a. The compositions may be in a suspension form or not (not specified).
Specifically, the difference is in that the drug component in the examined claims is a mometasone compound, while the reference claims recite a combination of mometasone and formoterol. This however would have been obvious to one of ordinary skill in the art as both drug components are known to be incorporated in formulations individually and in combination as evidenced by the references of record including Mueller-Walz. As such one of ordinary skill in the art would have been more than motivated to have selected the claimed drug components or combinations thereof for their known benefits and excepted effectiveness.
Specifically, the difference is in the arrangement of the limitations. The other difference is that reference claims recite that the formulation is in suspension form while the examined claims do not. However, examined claims are not restricted to any dosage form and encompass suspensions. The factual underpinning is that different active agents are considered alternatively usable species and as such one of ordinary skill in the art is more than capable of substituting one species / active agent for another with a reasonable expectation of success.
In this regard, the courts have held that “It is generally considered to be prima facie obvious to substitute components which are taught by the prior art to be well known and useful for the same purpose in order to form a composition that is to be used for an identical purpose. The motivation for substituting them flows from their having been used in the prior art, and from their being recognized in the prior art as useful for the same purpose. As shown by the recited teachings, instant claims are no more than the substituting conventional components of pharmaceutical active agents, and particularly steroids. It therefore follows that the instant claims define prima facie obvious subject matter. Cf. In re Ruff, 256 F.2d 590, 118 USPQ 340 (CCPA 1958).
Claims 1-5, 7, 9, 21-23 and 34-36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6-18, 20, 22-26 of copending Application No. 17/460,585 (US 20210386717) in view of Mueller-Walz (US 20070256685).
The obviousness Double Patenting rejection is appropriate because while the conflicting claims are not identical, they are not patentably distinct from the reference claims. The instant claims would have been obvious over the reference claims in view of Mueller-Walz.
Examined claims are drawn to a composition in a suspension form comprising a mometasone compound, ethanol and a propellant comprising 1,1-difluoroethane (R-152a).
Reference claims are drawn to a composition in a suspension form comprising a drug component comprising tiotropium bromide monohydrate which may also comprise mometasone and/or formoterol, ethanol and a propellant comprising R-152a.
Specifically, the difference is in that the drug component in the examined claims is a mometasone compound, while the reference claims recite a combination of tiotropium bromide monohydrate, mometasone and/or formoterol. This however would have been obvious to one of ordinary skill in the art as both drug components are known to be incorporated in formulations individually and in combination as evidenced by the references of record including Mueller-Walz. As such one of ordinary skill in the art would have been more than motivated to have selected the claimed drug components or combinations thereof for their known benefits and excepted effectiveness.
The factual underpinning is that different active agents are considered alternatively usable species and as such one of ordinary skill in the art is more than capable of substituting one species / active agent for another with a reasonable expectation of success.
In this regard, the courts have held that “It is generally considered to be prima facie obvious to substitute components which are taught by the prior art to be well known and useful for the same purpose in order to form a composition that is to be used for an identical purpose. The motivation for substituting them flows from their having been used in the prior art, and from their being recognized in the prior art as useful for the same purpose. As shown by the recited teachings, instant claims are no more than the substituting conventional components of pharmaceutical active agents, and particularly steroids. It therefore follows that the instant claims define prima facie obvious subject matter. Cf. In re Ruff, 256 F.2d 590, 118 USPQ 340 (CCPA 1958).
Claims 1-5, 7, 9, 21-23 and 34-36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4, 7-9, 13-16, 20, 22-26, 39 of copending Application No. 16/334,156 (US 20190388436) in view of Mueller-Walz (US 20070256685) and Keller et al (6,585,958).
The obviousness Double Patenting rejection is appropriate because while the conflicting claims are not identical, they are not patentably distinct from the reference claims. The instant claims would have been obvious over the reference claims in view of Mueller-Walz and Keller et al.
Examined claims are drawn to a composition in a suspension form comprising a mometasone compound, ethanol and a propellant comprising 1,1-difluoroethane (R-152a).
Reference claims are drawn to a composition in a suspension form comprising a drug component comprising beclomethasone dipropionate and formoterol fumarate dihydrate, a propellant comprising R-152a and glycerol. Depending claims add other active agents including ipratropium or tiotropium.
Specifically, the difference is in that the drug component in the examined claims is a mometasone compound, while the reference claims recite a combination of mometasone and formoterol. This however would have been obvious to one of ordinary skill in the art as both drug components are known to be incorporated in formulations individually and in combination as evidenced by the references of record including Mueller-Walz. As such one of ordinary skill in the art would have been more than motivated to have selected the claimed drug components or combinations thereof for their known benefits and excepted effectiveness.
Also as taught by Keller et al, the disclosed active agents are alternatively usable species in compositions treating respiratory diseases and specially in inhalation formulations. Keller et al also disclose an aerosol formulation comprising a solvent including ethanol and glycerol. Thus, based on the teachings of the art including Keller et al, ethanol and glycerol are also alternatively usable species for the same or similar formulations. Furthermore, Keller et al disclose that alternatively usable propellants include HFA 134, HFA 227, HFA 152a, etc.
The factual underpinning is that different active agents are considered alternatively usable species and as such one of ordinary skill in the art is more than capable of substituting one species / active agent for another with a reasonable expectation of success.
In this regard, the courts have held that “It is generally considered to be prima facie obvious to substitute components which are taught by the prior art to be well known and useful for the same purpose in order to form a composition that is to be used for an identical purpose. The motivation for substituting them flows from their having been used in the prior art, and from their being recognized in the prior art as useful for the same purpose. As shown by the recited teachings, instant claims are no more than the substituting conventional components of pharmaceutical active agents, and particularly steroids. It therefore follows that the instant claims define prima facie obvious subject matter. Cf. In re Ruff, 256 F.2d 590, 118 USPQ 340 (CCPA 1958).
Claims 1-5, 7, 9, 21-23 and 34-36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12, 15-17, 21-24 of copending Application No. 16/582,710 (US 20200016174) in view of Keller et al (6,585,958).
The obviousness Double Patenting rejection is appropriate because while the conflicting claims are not identical, they are not patentably distinct from the reference claims. The instant claims would have been obvious over the reference claims in view of Keller et al.
Examined claims are drawn to a composition in a suspension form comprising a mometasone compound, ethanol and a propellant comprising 1,1-difluoroethane (R-152a).
Reference claims are drawn to a composition in a suspension form comprising a drug component comprising beclomethasone dipropionate and formoterol fumarate dihydrate and a propellant comprising R-152a. Depending claims add other active agents including ipratropium or tiotropium.
Specifically, the difference is in the arrangement of the limitations. The factual underpinning is that different active agents are considered alternatively usable species and as such one of ordinary skill in the art is more than capable of substituting one species / active agent for another with a reasonable expectation of success. Also as taught by Keller et al, the disclosed active agents are alternatively usable species in compositions treating respiratory diseases and specially in inhalation formulations.
Furthermore, Keller et al disclose that alternatively usable propellants include HFA 134, HFA 227, HFA 152a, etc.
In this regard, the courts have held that “It is generally considered to be prima facie obvious to substitute components which are taught by the prior art to be well known and useful for the same purpose in order to form a composition that is to be used for an identical purpose. The motivation for substituting them flows from their having been used in the prior art, and from their being recognized in the prior art as useful for the same purpose. As shown by the recited teachings, instant claims are no more than the substituting conventional components of pharmaceutical active agents, and particularly steroids. It therefore follows that the instant claims define prima facie obvious subject matter. Cf. In re Ruff, 256 F.2d 590, 118 USPQ 340 (CCPA 1958).
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Mueller-Walz (US 20070256685)
Muller-Walz teach a pharmaceutical aerosol formulation for use in a metered dose inhaler (MDI) comprising formoterol fumarate di-hydrate in suspension, a propellant and ethanol. Steroids may be selected from the group consisting of budesonide, mometasone, fluticasone, beclomethasone, mometasone furoate, etc (See [0033] and claim 7). Suitable propellants for use in metered-dose aerosols include 1,1,2,2-tetrafluoroethane (HFA 134), difluoroethane (HFA 152a), 1,1,1,2,3,3,3-heptafluoropropane (HFA 227) and the like (See [0040] and claim 32). Ethanol is employed in the said formulations in anhydrous form. And is present in amounts of less than 2.5% by weight to about 1% by weight, e.g. 1 to 1.5% by weight, more particularly 1 to about 1.45% by weight (See [0045]).
The said aerosol formulations can contain no, or substantially no surfactant, i.e. contain less than approximately 0.0001% by weight of surface-active agents (See [0047]).
It is disclosed that the said formulations find use as medicinal aerosol preparations for the treatment of disease states of the lung, for example asthma, COPD, etc, (See [0054]).
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See ([0032]).
Osborn et al (6,432,415).
Osborn et al teach bioadhesive formulations to deliver, for both local and systemic effects, a wide variety of drugs of varying degrees of solubility. These formulations can be gels or aerosols and comprise a solvent system comprising a volatile solvent and water, a solubilizing agent or a dispersing agent, or a mixture thereof, and a pharmaceutical (See abstract).
It is disclosed that there is an unexpected increase in solubility of propellant 152a which is particularly advantageous for aerosol formulations comprising Propellant 152a because this reduces the need for using high amounts of ethanol to dissolve the Propellant (See Col.8, lines 56-67 and col. 9, lines 1-10).
In one aspect, the propellant is 1,1-difluoroethane also known as propellant 152a, commercially available under the trade mark DymelRTM (See Col. 6, lines 27-34).
Pharmaceutical active agents include steroidal anti-inflammatory agents and adrenergics, etc, (See Col. 12, line 32 to Col. 13, line 10).
Keller et al (6,585,958).
Keller et al teach a pressure-liquefied propellant mixture for aerosols, comprising HFA propellants which can overcome problems with respect to suspension and solution aerosols and thus improved medicinal aerosol formulations can be obtained.
Keller et al disclose aerosol formulations that may comprise one or more of the active agents including beclomethasone, mometasone, fluticasone, formoterol, salbutamol, tiotropium bromide, etc.
The propellants include HFA-134, HFA 227 and HFA 152a. Suitable cosolvents include ethanol and glycerol.
Finch et al (US 20140248357).
Finch et al teach a composition for treatment of inflammatory respiratory disease by inhalation comprising a glitazone enantiomer (See abstract and [0018]). The said compositions may be used in combination with other drugs that are used in the treatment or suppression of the diseases or conditions for which present compounds are useful (See [0046]). Suitable therapeutic agents include beclomethasone dipropionate, fluticasone propionate, formoterol fumarate, mometsaone furoate, etc, (See [0047] and [0050]).
Finch et al also disclose that for delivery by inhalation, the active compound is preferably in the form of microparticles. These may be prepared by a variety of techniques, including micronisation. Hence the average particle size is denoted as equivalent d50. For inhaled use a d50 of less than 10 microns, preferably less than 5 microns is desired (See [0053]).
Finch et al state that the said composition may be prepared as a suspension for delivery from an aerosol in a liquid propellant, for example for use in a pressurised metered dose inhaler (PMDI). Propellants suitable for use in a PMDI are known to the skilled person, and include HFA-134a, HFA-227 (See [0054]).
The compositions may be dosed as described depending on the inhaler system used. In addition to the active compounds, the administration forms may additionally contain excipients, such as, surface-active substances, preservatives, flavorings, fillers, etc, (See [0058]).
Sequeira et al (5,837,699).
Sequeira et al teach administration of aerosolized particles of mometasone furoate in the form of dry powders, solutions, or aqueous suspension for treating corticosteroid-responsive diseases of the surfaces of upper and/or lower airway passages and/or lungs. Claimed and disclosed is a method of treating a corticosteroid-responsive disease of the upper or lower airway passages by administering a once-a-day amount of aerosolized particles of mometasone furoate to the patient (See Abstract and Summary).
Sequeira et al state that “We have surprisingly discovered that mometasone furoate exhibits superior anti-inflammatory effects in treating airway passage diseases such as asthma and allergic rhinitis by acting on surfaces of the upper and lower airways passages and lungs while having a substantially minimum systemic effect” (See Col. 3, lines 24-29).
It is disclosed that the devices found useful for providing measured substantially non-systematically bioavailable amounts of aerosolized mometasone furoate for delivery to the oral airway passages and lungs by oral inhalation include pressurized metered-dose inhalers ("MDI") which deliver aerosolized particles suspended in propellants such as HFC-134A or HFC-227 with or without surfactants and suitable bridging agents (See Col. 5, lines 18-28).
Sequeira et al state that the amount of mometasone furoate suspension administered with metered dose inhalers with standard propellant is about 10 to 5000 mcg/day or 25 to 200 mcg/day, or 25-50 mcg/day; etc, (See Col. 6, line 49 to 56).
Response to Arguments
Applicant's arguments filed 12/15/25 have been fully considered but they are not persuasive.
Applicant’s amendments to the claims have necessitated modified grounds of rejections. Applicant’s arguments so far as they pertain to the maintained references and rejections are discussed below.
Applicant’s first argument is regarding the rejection of claims over Sequeira et al, in combination with Corr et al and Backstrom (See Remarks, pages 5-9).
These arguments are moot since the amendments requiring the water to be present at less than 500 ppm removes Sequeira et al as prior art.
Applicant also argues against the combination of references and states that Corr et al teach solutions and not suspensions and Backstrom et al teaches a number of active agents, teaches surfactants and a number of propellants. Applicant argues that one of ordinary skill in the art would not be motivated to have combined the teachings of Corr et al and Backstrom et al with Sequeira et al.
The above arguments are not persuasive. Firstly, Sequeira et al is not a prior art in the current and modified rejections. While Corr et al teach solution formulations comprising different active agents, the reference is relied upon for its teaching and suggestion on selecting HFA-152a propellant and one of ordinary skill in the art would clearly be motivated to substitute Berry et al’s HFA propellant with HFA-152 per Corr et al’s disclosure and as evidenced by DAIKIN HFC-152a product information and/or UNFCCC both of which provide added motivation to one of ordinary skill in the art to select a better propellant such as HFA 152a. Backstrom et al also teach that the same formulations can have any of the listed active agents and while HFA 134 and 227 are suitable propellants that HFA 152 is better for the environment. Thus, it would have been obvious to one of ordinary skill in the art that substituting HFA 152 of Corr et al for Berry et al’s suspension formulations comprising mometasone and ethanol would lead to success.
Regarding the long list of active agents in Backstrom et al, it is noted that the fact that Backstrom et al identifies other possible active ingredients does not make its teaching of a suspension composition comprising mometasone, ethanol and an HFA propellant any less obvious. See Merck & Co., Inc. v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989) (explaining that a reference’s disclosure of “a multitude of effective combinations does not render any particular formulation less obvious”).
Thus, the primary reference teaches inhalable compositions in suspension form comprising mometasone furoate, ethanol and an HFA. Corr et al motivates one of ordinary skill in the art to substitute one propellant for another. Thus, claims are properly rendered obvious.
Corr ‘711 teach that “There is a need for a MDI aerosol formulation that has a reduced GWP in comparison with R-134a and R-227ea, that has acceptable flammability and toxicity performance and which forms stable suspensions or solutions with a range of pharmaceutical actives and with reduced irritancy”.
Corr et al ‘711 specifically discloses that the HFA 227 and HFA 134 result in environmental issues and that “they are unlikely to be acceptable for use in the MDI sector for many years, if at all’.
Corr et al (US 10,792,256) teach “We have found that a propellant comprising 1,1-difluoroethane (HFA-152a) can be used to successfully deliver salmeterol-based drug formulations using an MDI. These formulations can exhibit improved chemical stability, particularly where the formulations contain low amounts of water, improved aerosolisation performance for improved drug delivery, good suspension stability, reduced GWP, good compatibility with standard uncoated aluminium cans as well as good compatibility with standard valves and seals”.
Furthermore, Applicant appears to assign a very narrow skill set to one skilled in the art. In response to applicant’s argument that one of ordinary skill in the art would not have been motivated to substitute HFA 152 for HFA 134 or 227, MPEP states that “the obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). As indicated in the rejection supra, 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 substituted HFA 152, a propellant that is less damaging to the environment for HFA 134 or 227, which are known to have some negative impact on the ozone and environment.
Regarding an ordinary artisan MPEP 2141 states that ““A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton.” KSR, 550 U.S. at 421, 82 USPQ2d at 1397. “[I]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle.” Id. at 420, 82 USPQ2d at 1397. Office personnel may also take into account “the inferences and creative steps that a person of ordinary skill in the art would employ.” Id. at 418, 82 USPQ2d at 1396; and 2) MPEP 716.07: “It is to be presumed also that skilled workers would as a matter of course, if they do not immediately obtain desired results, make certain experiments and adaptations, within the skill of the competent worker.”
It is further noted that in addition to the teaching of Corr ‘711, the DAIKIN HFC-152a product information and/or UNFCCC both provided added motivation to one of ordinary skill in the art to select a better propellant such as HFA 152a.
With regards to the rejection of claims on the ground of nonstatutory double patenting over claims of Patents or copending Applications in view of secondary references as stated above, Applicant makes analogous arguments including the difference between solutions and suspensions, the different active agents, etc. Applicant requests a withdrawal of these rejections (See remarks, pages 16-24).
The arguments are not sufficient because the rejection clearly stated that the main difference is in the active agents which was rendered obvious by the secondary references including Mueller-Walz, Keller et al and Finch et al, based on which it would be obvious to substitute one active agent for another in the same composition with a reasonable expectation of success. Thus, the factual underpinning is that different active agents are considered alternatively usable species and as such one of ordinary skill in the art is more than capable of substituting one species / active agent for another with a reasonable expectation of success.
In this regard, the courts have held that “It is generally considered to be prima facie obvious to substitute components which are taught by the prior art to be well known and useful for the same purpose in order to form a composition that is to be used for an identical purpose. The motivation for substituting them flows from their having been used in the prior art, and from their being recognized in the prior art as useful for the same purpose. As shown by the recited teachings, instant claims are no more than the substituting conventional components of pharmaceutical active agents, and particularly steroids. It therefore follows that the instant claims define prima facie obvious subject matter. Cf. In re Ruff, 256 F.2d 590, 118 USPQ 340 (CCPA 1958).
The arguments are also not found persuasive for the same reasons as stated above.
Regarding the rejection of claims under obviousness type double patenting over co-pending Application No. 16/334,156, 16/582,710, 16/582,964, 17/944,666 and 17/969,250 Applicant made no argument and asked for these rejections to be held in abeyance.
The rejections are maintained.
Claims 1-5, 7, 9, 21-23 and 34-36 are rejected.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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 on M-F, 7-5 EST.
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/Mina Haghighatian/