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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 06/15/26 has been entered.
Receipt is acknowledged of Amendments and Remarks filed on 06/15/26. Claims 1 and 21 have been amended, new claim 37 has been added and claims 34-36 have been cancelled. Accordingly, claims 1-5, 7, 9, 21-23 and 37 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Rejections and/or objections not reiterated from the previous Office Action are hereby withdrawn.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.
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 37 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), Mueller-Walz (US 20070256685) and/or Backstrom et al (6,932,962).
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 Backstrom 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 salmeterol compound, optionally at least on long-acting muscarinic antagonist, at least one corticosteroid including mometasone, 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.
Backstrom et al teach pharmaceutical aerosol formulation wherein the formulation comprises a propellant such as 1,1-difluoroethane (P152a) for inhalation via a metered dose inhaler. The said formulation may comprise a small amount of ethanol (normally up to 5% but possibly up to 20%, by weight). The active agents can be micronized and in a suspension form. Backstrom et al disclose that the said pharmaceutical aerosol formulation comprises a medicament selected from the group consisting of salbutamol, terbutaline, rimiterol, fenoterol, reproterol, adrenaline, pirbuterol, isoprenaline, orciprenaline, bitolterol, salmeterol, formoterol, clenbuterol, procaterol, broxaterol, picumeterol, mabuterol, ipratropium bromide, beclomethasone, fluticasone, budesonide, tipredane, dexamethasone, betamethasone, fluocinolone, triamcinolone acetonide, mometasone, anti-allergic medicaments, expectorants, mucolytics, antihistamines, cyclooxygenase inhibitors, leukotriene synthesis inhibitors, leukotriene antagonists, phospholipase-A2 (PLA2) inhibitors, platelet aggregating factor (PAF) antagonists, prophylactics of asthma, antiarrhythmic medicaments, tranquilisers, cardiac glycosides, hormones, anti-hypertensive medicaments, antidiabetic medicaments, antiparasitic medicaments, anticancer medicaments, sedatives, analgesic medicaments, antibiotics, antirheumatic medicaments, immunotherapeutic agents, antifungal medicaments, antihypotension medicaments, vaccines, antiviral medicaments, proteins, peptides, vitamins, cell surface receptor blockers, antioxidants, free radical scavengers, and organic salts of N,N′-diacetylcystine (See Columns 2-3 and claims 12-13).
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. As taught by the prior art references it would have been obvious to one of ordinary skill in the art to have selected any of the known and disclosed pharmaceutically active agents for the same base dosage formulation 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 37 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; 11,077,076; 11,311,502; 11,103,480; 11,260,052; 11,559,507; 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) and/or Backstrom et al (6,932,962).
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 and/or Backstrom 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.
Furthermore, Backstrom et al teach pharmaceutical aerosol formulation wherein the formulation comprises a propellant such as 1,1-difluoroethane (P152a) for inhalation via a metered dose inhaler. The said formulation may comprise a small amount of ethanol (normally up to 5% but possibly up to 20%, by weight). The active agents can be micronized and in a suspension form. Backstrom et al disclose that the said pharmaceutical aerosol formulation comprises a medicament selected from the group consisting of salbutamol, terbutaline, rimiterol, fenoterol, reproterol, adrenaline, pirbuterol, isoprenaline, orciprenaline, bitolterol, salmeterol, formoterol, clenbuterol, procaterol, broxaterol, picumeterol, mabuterol, ipratropium bromide, beclomethasone, fluticasone, budesonide, tipredane, dexamethasone, betamethasone, fluocinolone, triamcinolone acetonide, mometasone, anti-allergic medicaments, expectorants, mucolytics, antihistamines, cyclooxygenase inhibitors, leukotriene synthesis inhibitors, leukotriene antagonists, phospholipase-A2 (PLA2) inhibitors, platelet aggregating factor (PAF) antagonists, prophylactics of asthma, antiarrhythmic medicaments, tranquilisers, cardiac glycosides, hormones, anti-hypertensive medicaments, antidiabetic medicaments, antiparasitic medicaments, anticancer medicaments, sedatives, analgesic medicaments, antibiotics, antirheumatic medicaments, immunotherapeutic agents, antifungal medicaments, antihypotension medicaments, vaccines, antiviral medicaments, proteins, peptides, vitamins, cell surface receptor blockers, antioxidants, free radical scavengers, and organic salts of N,N′-diacetylcystine (See Columns 2-3 and claims 12-13).
For example, the claims in Patent No. 11,690,823, are drawn to a method of improving the stability of a pharmaceutical composition comprising: adding a propellant component consisting of (HFA-152a), to the pharmaceutical composition, the pharmaceutical composition comprising a drug component comprising a salt of glycopyrrolate, a beta-2-agonist and a corticosteroid, ethanol, water of less than 50 ppm and dissolved oxygen levels of less than 1000 ppm.
The difference is that the claims requiring a corticosteroid do not expressly disclose it being mometasone (The specification states that the said corticosteroid may be mometasone). However as shown by the secondary references, the active agent may be selected from a number of disclosed active agents including glycopyrrolate, mometasone or other corticosteroids.
Another example relates to Patent No. 11,559,507, where the claims are directed to a pharmaceutical composition comprising: formoterol, at least one corticosteroid selected from the group consisting of beclomethasone dipropionate and fluticasone propionate; a propellant component comprising at least 90 weight % 1,1-difluoroethane (R-152a); ethanol and wherein the pharmaceutical composition is in the form of a suspension. Water and oxygen limitations are also recited.
Another example relates to Patent No. 10,792,256, where the claims are directed to a pharmaceutical composition for a metered dose inhaler comprising:(i) a drug component consisting of salmeterol or salts thereof either alone or together with at least one long acting muscarinic antagonist (LAMA) and/or at least one corticosteroid selected from mometasone, beclomethasone, fluticasone and the pharmaceutically acceptable salts and esters thereof; and (ii) a propellant component comprising 1,1-difluoroethane (HFA-152a), wherein the composition contains greater than 0.5 ppm and less than 500 ppm of water based on the total weight of the pharmaceutical composition and comprises ethanol.
Again, the difference is the active agent. The prior art references teach that the same formulation base may comprise any of the recited active agents.
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. As taught by the prior art references it would have been obvious to one of ordinary skill in the art to have selected any of the known and disclosed pharmaceutically active agents for the same base dosage formulation with a reasonable expectation of success.
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 37 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 8, 12, 15-21 and 23-24 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 37 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 37 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) and Backstrom et al (6,932,962).
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 Backstrom 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 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.
Furthermore, Backstrom et al teach pharmaceutical aerosol formulation wherein the formulation comprises a propellant such as 1,1-difluoroethane (P152a) for inhalation via a metered dose inhaler. The said formulation may comprise a small amount of ethanol (normally up to 5% but possibly up to 20%, by weight). The active agents can be micronized and in a suspension form. Backstrom et al disclose that the said pharmaceutical aerosol formulation comprises a medicament selected from the group consisting of salbutamol, terbutaline, rimiterol, fenoterol, reproterol, adrenaline, pirbuterol, isoprenaline, orciprenaline, bitolterol, salmeterol, formoterol, clenbuterol, procaterol, broxaterol, picumeterol, mabuterol, ipratropium bromide, beclomethasone, fluticasone, budesonide, tipredane, dexamethasone, betamethasone, fluocinolone, triamcinolone acetonide, mometasone, anti-allergic medicaments, expectorants, mucolytics, antihistamines, cyclooxygenase inhibitors, leukotriene synthesis inhibitors, leukotriene antagonists, phospholipase-A2 (PLA2) inhibitors, platelet aggregating factor (PAF) antagonists, prophylactics of asthma, antiarrhythmic medicaments, tranquilisers, cardiac glycosides, hormones, anti-hypertensive medicaments, antidiabetic medicaments, antiparasitic medicaments, anticancer medicaments, sedatives, analgesic medicaments, antibiotics, antirheumatic medicaments, immunotherapeutic agents, antifungal medicaments, antihypotension medicaments, vaccines, antiviral medicaments, proteins, peptides, vitamins, cell surface receptor blockers, antioxidants, free radical scavengers, and organic salts of N,N′-diacetylcystine (See Columns 2-3 and claims 12-13).
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. As taught by the prior art references it would have been obvious to one of ordinary skill in the art to have selected any of the known and disclosed pharmaceutically active agents for the same base dosage formulation with a reasonable expectation of success.
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 37 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7-9, 13-16, 20, 22-23, 26, 39 and 41 of copending Application No. 16/334,156 (US 20190388436) in view of Mueller-Walz (US 20070256685), Keller et al (6,585,958) and/or Backstrom et al (6,932,962).
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 and/or Backstrom 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.
Furthermore, Backstrom et al teach pharmaceutical aerosol formulation wherein the formulation comprises a propellant such as 1,1-difluoroethane (P152a) for inhalation via a metered dose inhaler. The said formulation may comprise a small amount of ethanol (normally up to 5% but possibly up to 20%, by weight). The active agents can be micronized and in a suspension form. Backstrom et al disclose that the said pharmaceutical aerosol formulation comprises a medicament selected from the group consisting of salbutamol, terbutaline, rimiterol, fenoterol, reproterol, adrenaline, pirbuterol, isoprenaline, orciprenaline, bitolterol, salmeterol, formoterol, clenbuterol, procaterol, broxaterol, picumeterol, mabuterol, ipratropium bromide, beclomethasone, fluticasone, budesonide, tipredane, dexamethasone, betamethasone, fluocinolone, triamcinolone acetonide, mometasone, anti-allergic medicaments, expectorants, mucolytics, antihistamines, cyclooxygenase inhibitors, leukotriene synthesis inhibitors, leukotriene antagonists, phospholipase-A2 (PLA2) inhibitors, platelet aggregating factor (PAF) antagonists, prophylactics of asthma, antiarrhythmic medicaments, tranquilisers, cardiac glycosides, hormones, anti-hypertensive medicaments, antidiabetic medicaments, antiparasitic medicaments, anticancer medicaments, sedatives, analgesic medicaments, antibiotics, antirheumatic medicaments, immunotherapeutic agents, antifungal medicaments, antihypotension medicaments, vaccines, antiviral medicaments, proteins, peptides, vitamins, cell surface receptor blockers, antioxidants, free radical scavengers, and organic salts of N,N′-diacetylcystine (See Columns 2-3 and claims 12-13).
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. As taught by the prior art references it would have been obvious to one of ordinary skill in the art to have selected any of the known and disclosed pharmaceutically active agents for the same base dosage formulation with a reasonable expectation of success.
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 37 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 25, 27-41, 43-44 and 46-56 of copending Application No. 16/582,710 (US 20200016174) in view of Keller et al (6,585,958) and/or Backstrom et al (6,932,962).
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 and/or Backstrom 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.
Furthermore, Backstrom et al teach pharmaceutical aerosol formulation wherein the formulation comprises a propellant such as 1,1-difluoroethane (P152a) for inhalation via a metered dose inhaler. The said formulation may comprise a small amount of ethanol (normally up to 5% but possibly up to 20%, by weight). The active agents can be micronized and in a suspension form. Backstrom et al disclose that the said pharmaceutical aerosol formulation comprises a medicament selected from the group consisting of salbutamol, terbutaline, rimiterol, fenoterol, reproterol, adrenaline, pirbuterol, isoprenaline, orciprenaline, bitolterol, salmeterol, formoterol, clenbuterol, procaterol, broxaterol, picumeterol, mabuterol, ipratropium bromide, beclomethasone, fluticasone, budesonide, tipredane, dexamethasone, betamethasone, fluocinolone, triamcinolone acetonide, mometasone, anti-allergic medicaments, expectorants, mucolytics, antihistamines, cyclooxygenase inhibitors, leukotriene synthesis inhibitors, leukotriene antagonists, phospholipase-A2 (PLA2) inhibitors, platelet aggregating factor (PAF) antagonists, prophylactics of asthma, antiarrhythmic medicaments, tranquilisers, cardiac glycosides, hormones, anti-hypertensive medicaments, antidiabetic medicaments, antiparasitic medicaments, anticancer medicaments, sedatives, analgesic medicaments, antibiotics, antirheumatic medicaments, immunotherapeutic agents, antifungal medicaments, antihypotension medicaments, vaccines, antiviral medicaments, proteins, peptides, vitamins, cell surface receptor blockers, antioxidants, free radical scavengers, and organic salts of N,N′-diacetylcystine (See Columns 2-3 and claims 12-13).
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. As taught by the prior art references it would have been obvious to one of ordinary skill in the art to have selected any of the known and disclosed pharmaceutically active agents for the same base dosage formulation with a reasonable expectation of success.
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 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]).
PNG
media_image1.png
200
400
media_image1.png
Greyscale
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).
Berry et al (6,068,832),
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).
Corr et al (WO 2012156711),
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 (6,932,962),
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).
Backstrom et al disclose that the said pharmaceutical aerosol formulation comprises a medicament selected from the group consisting of salbutamol, terbutaline, rimiterol, fenoterol, reproterol, adrenaline, pirbuterol, isoprenaline, orciprenaline, bitolterol, salmeterol, formoterol, clenbuterol, procaterol, broxaterol, picumeterol, mabuterol, ipratropium bromide, beclomethasone, fluticasone, budesonide, tipredane, dexamethasone, betamethasone, fluocinolone, triamcinolone acetonide, mometasone, anti-allergic medicaments, expectorants, mucolytics, antihistamines, cyclooxygenase inhibitors, leukotriene synthesis inhibitors, leukotriene antagonists, phospholipase-A2 (PLA2) inhibitors, platelet aggregating factor (PAF) antagonists, prophylactics of asthma, antiarrhythmic medicaments, tranquilisers, cardiac glycosides, hormones, anti-hypertensive medicaments, antidiabetic medicaments, antiparasitic medicaments, anticancer medicaments, sedatives, analgesic medicaments, antibiotics, antirheumatic medicaments, immunotherapeutic agents, antifungal medicaments, antihypotension medicaments, vaccines, antiviral medicaments, proteins, peptides, vitamins, cell surface receptor blockers, antioxidants, free radical scavengers, and organic salts of N,N′-diacetylcystine (See Columns 2-3 and claims 12-13).
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.
Response to Arguments
Applicant's arguments filed 06/15/26 have been fully considered but they are not all 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.
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, Applicants arguments are mainly that “it would not have been obvious to replace the drug component of the examined claims with the drug component of the reference claims in view of the secondary references. Applicant requests a withdrawal of these rejections (See remarks, pages 10-14).
Firstly, it is noted that, the instant claims are a modification or variant of the reference claims. The doctrine of double patenting seeks to prevent the unjustified extension of patent exclusivity beyond the term of a patent. The public policy behind this doctrine is that: The public should….be able to act on the assumption that upon the expiration of the patent it will be free to use not only the invention claimed in the patent but also modifications or variants which would have been obvious to those of ordinary skill in the art at the time the invention was made. In re Zickendraht, 319 F.2d 225,323, 138 USPQ 22, 27 (CCPA 1963) (Rich, J., concurring). Double patenting results when the right to exclude granted by a first patent is unjustly extended by the grant of a later issued patent or patents. In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982).
Secondly, the arguments are not sufficient to overcome the rejections because the rejections 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. Furthermore, as taught by Backstrom et al, the same composition base may comprise any one or more of many known active agents 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).
For example, the claims of Patent No. 10,792,256 are directed to a drug component consisting of salmeterol, a long-acting muscarinic agent and a corticosteroid including mometasone. Examined claims are directed to a composition comprising mometasone or mometasone furoate. 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. Backstrom et al teach pharmaceutical aerosol formulation wherein the medicament may be selected from salmeterol, formoterol, mometasone, etc. Thus, there is overwhelming evidence that not only it is obvious to substitute active agents in the same formulation with a reasonable expectation of success, but that this is a common practice in the field of pharmaceuticals. This is also evident from the very large portfolio of Patents and Applications involved in the above cited Double patenting rejections where the only difference is the main difference between claim sets if the active agent.
Regarding the rejection of claims over the reference claims in U.S. Patent No. 11,690,823; 11,179,366; 11,077,076; 11,311,502; 11,103,480; 11,260,052; 11,559,507; 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), Applicant’s argument is that “The [Appellant] respectfully submits that the Examiner's rejection failed to provide an appropriate analysis to support the obviousness-type double patenting rejection. Specifically, as the MPEP explains, a nonstatutory double patenting rejection under an obviousness analysis should make clear: (A) The differences between the inventions defined by the conflicting claims -- a claim in the patent compared to a claim in the application; and (B) The reasons why a person of ordinary skill in the art would conclude that the invention defined in the claim at issue would have been an obvious variation of the invention defined in a claim in the patent” (See Remarks, pages 10-12).
The above arguments are also not found persuasive for the same reasons as stated above.
Specifically, it is noted that while collectively rejecting claims in multiple Patents, the analysis is the same. additionally, the analysis states the differences between the examined claims and the reference claims and why the said difference(s) is not patentably distinguished. The secondary references, as stated above, clearly show that it is both obvious to substitute one pharmaceutically active agent for another in the same formulation but that it is commonly practiced.
For example, the claims in Patent No. 11,690,823, are drawn to a method of improving the stability of a pharmaceutical composition comprising: adding a propellant component consisting of (HFA-152a), to the pharmaceutical composition, the pharmaceutical composition comprising a drug component comprising a salt of glycopyrrolate, a beta-2-agonist and a corticosteroid, ethanol, water of less than 50 ppm and dissolved oxygen levels of less than 1000 ppm.
The difference is that the claims requiring a corticosteroid do not expressly disclose it being mometasone (The specification states that the said corticosteroid may be mometasone). However as shown by the secondary references, the active agent may be selected from a number of disclosed active agents including glycopyrrolate, mometasone or other corticosteroids.
Another example relates to Patent No. 11,559,507, where the claims are directed to a pharmaceutical composition comprising: formoterol, at least one corticosteroid selected from the group consisting of beclomethasone dipropionate and fluticasone propionate; a propellant component comprising at least 90 weight % 1,1-difluoroethane (R-152a); ethanol and wherein the pharmaceutical composition is in the form of a suspension. Water and oxygen limitations are also recited.
Again, the difference is that the claims require formoterol and a corticosteroid which is beclomethasone dipropionate and fluticasone propionate. However as shown by the secondary references, the active agent may be selected from a number of disclosed active agents including formoterol, beclomethasone, fluticasone, mometasone or other active agents.
Another example relates to Patent No. 10,792,256, where the claims are directed to a pharmaceutical composition for a metered dose inhaler comprising:(i) a drug component consisting of salmeterol or salts thereof either alone or together with at least one long acting muscarinic antagonist (LAMA) and/or at least one corticosteroid selected from mometasone, beclomethasone, fluticasone and the pharmaceutically acceptable salts and esters thereof; and (ii) a propellant component comprising 1,1-difluoroethane (HFA-152a), wherein the composition contains greater than 0.5 ppm and less than 500 ppm of water based on the total weight of the pharmaceutical composition and comprises ethanol.
Again, the difference is the active agent. The prior art references teach that the same formulation base may comprise any of the recited active agents.
Regarding the argument that it would not have been obvious to one of ordinary skill in the art to make the modifications, 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.”
An ordinarily skilled artisan would reasonably expect success in modifying the compositions of the reference claims in view of the teachings of the prior art as proposed because the same formulation can easily be envisioned as containing other active agents with a reasonable expectation of success.
The known work in the field of pharmaceuticals, especially, inhalable formulations, would have prompted variations of it for use in the same field based on design incentives or other market forces where the variations are predictable to one of ordinary skill in the art. MPEP 2144.09.II.
Regarding the rejection of claims under obviousness type double patenting over co-pending Application No. 17/944,666 and 17/969,250 Applicant made no argument.
The rejections are maintained.
Claims 1-5, 7, 9, 21-23 and 37 are rejected.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sue X. Liu can be reached on 571-272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Mina Haghighatian/
Prosecution Insights