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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 05/01/2026, is acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the examiner. See attached copy of PTO-1449.
Status of Application
Applicants' arguments/remarks filed 05/01/2026 are acknowledged. Claims 1 and 16 are currently amended. Claims 1-4, 6-10, 16-17 and 22-24 are examined on the merits within and are currently pending.
Maintained Rejections
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or non-obviousness.
Claims 1-4, 6-10, 16-17 and 22-24 are rejected under 35 U.S.C. 103 as being unpatentable over Arnold et al., (US 5,478,578) in view of Walker et al. (WO 2014/140648 Al) and further in view of Spargo et al (WO 2016/128742 Al) and Abbott-Banner (WO 2015/173551 Al).
Claims 1, 2 and 4,
Arnold et al. teach in order to control and optimize the amount of inhalable active substance released when drugs are administered as inhalation powders, the invention calls for the use of auxiliaries consisting of mixtures of coarser particles (average particle size >20 µm) and finer particles (average particle size <10 µm). (Abs). The active substance micronized into inhalable particles is combined with suitable quantities of a mixture of one or more physiologically acceptable excipients, one component of the excipient mixture having a mean particle size of less than about 10 µm and the other having a mean particle size greater than about 20 µm, the average particle size generally being preferably less than 80 µm. (Col. 1, lines 48-54), which are overlapping with the fine and coarse particle sizes that applicants claim. Pharmaceutically suitable and physiologically harmless excipients for inhalation purposes are known. Examples include disaccharides such as lactose; Lactose and glucose are preferred (Col. 2, lines 23-24, 26 & 30). The fine glucose particles are present in an amount of from 0-11% relative to the total weight to the dry powder pharmaceutical composition. The percentages are calculated from percentages of fine glucose particles in the dry powder composition including the drugs in Example 1, col. 2, lines 49-55). The 0-11% of fine particles are overlapped with the 2.0-7.5 wt% in claim 1, and 3.5-4.0 % in claim 2 that the applicants claim. Average particle size is D50. It would be obvious for one of skills in the art to select glucose or lactose for dried particle formulation for inhaling. One with skill in the art, is known for solving the same problem, is represented with design choices, may modify the teachings of the prior arts until they can achieve better outcome results.
Arnold et al. do not teach the ensifentrine particles.
Walker et al. teach RPL554/ensifentrine (Abs) and preferably suitable for delivery from a dry powder inhaler (DPI), a solution which is suitable for delivery from a nebulizer, or a solution or suspension which is suitable for delivery from a pressurized metered dose inhaler (PMDI). (pg. 9, line 7-9). A micronized RPL554 combination is blended with milled lactose, in which coarse lactose particle having MMD of about 60 µm to about 90 µm and the fine particles have a MMD of less than 15 µm). (pg. 40, lines 14-16), which are overlapping with applicants’ claim 1-(ii) of Dv50 of from 50 µm to 80 µm and 1-(iii) of fine lactose particles having a Dv50 of from 5 µm to 10 µm, and claim 4 of coarse laclose particle having D50 55-65 µm. MMD is D50 value, also known as mass-median- diameter (MMD) is the diameter which divides the particles into two groups with equivalent weight / mass. Each sieve is weighed, and the volume of each fraction is calculated in percent by weight, providing a mass-related distribution.
Walker et al. do not teach percentage of ensifentrine particles within range of 3.5-6% relative to the total weight of the dry powder pharmaceutical composition.
Spargo et al. teach RPL554/ensifentrine and its salts (Abs), for inhalation (pg. 2, 1st par.).
A dry powder pharmaceutical composition may comprise from 0.2 to 5.0 wt% of a salt of RPL554. (pg. 8, lines 10-15).
Abbott-Banner teaches RPL554/ensifentrine (pg. 1, 3rd last par.), in pharmaceutical compositions, which may be administered to the subject by any acceptable route of administration including, but not limited to, inhaled, oral, nasal, topical (including transdermal) and parenteral modes of administration. Administration by inhalation is preferred. (pg. 9, 3rd par.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare pharmaceutical composition for inhaling with monosaccharide fine and coarse particles, their particle sizes and percentage of fine particles taught by Arnold et al., the drug is RPL554/ensifentrine, taught by Abbott-Banner, Spargo et al. and Walker et al., the sizes of fine and coarse lactose particles taught by Walker et al., and the percentage of RPL554/ensifentrine taught by Spargo et al. since they have proven it would be feasible to do so.
With regard to claim 3,
Arnold et al. teach powder for inhalation comprising a micronized active substance and a physiologically acceptable excipient comprising a mixture containing a fine fraction having an average particle size in the range of less than 10 µm and a coarse fraction having an average particle size in the range of from about 20 µm to about 150 µm, wherein the weight ratio of micronized active substance to the physiologically acceptable excipient mixture is from about 0.01:5 to 0.1:5. (Claim 1, Col. 2 and 3), which mean in
5 g of GI+GII, there are 0.01 or 0.1 g of W. Or, in
100 g of GI+GII, there are 0.2 or 2 g of W.
Powder for inhalation according to claim 1 characterized in that the weight ratio of the fine fraction to the coarse fraction in the physiologically acceptable excipient mixture is between 1:99 and 95:5. (Claim 2, Col. 3), which mean in
a)1g of GI there are 99g of GII or
b)95g of GI, there are 5g of GII
a)in 100g of GI+GII has 1g of GI, 99g of GII and 0.2 or 2 g of W, so
99/(100+0.2 or 2) x 100 = 98.8 or 97% of GII in total composition.
b)in 100g of GI GI+GII has 95g of GI, 5g of GII and 0.2 or 2 g of W, so
5/(100+0.2 or 2) x 100 = 5 or 4.9% of GII in total composition.
Percentage of GII in total composition can be from 4.9%-98.8%.
With regard to claims 6 and 22, Abbott-Banner teaches a representative composition for use in a DPI comprises dry lactose particle and micronized particles of the active agent. Such a dry powder formulation can be made by combining lactose with the active agent and then dry blending the components. Alternatively, if desired, the active agent can be formulated without an excipient. (pg. 11, last par.). This means the active agent, ensifentrine particles comprise up to 100% ensifentrine or a pharmaceutically acceptable salt of ensifentrine.
With regard to claims 7 and 23
Arnold et al. teach in Example 1 the mixture contains, per capsule, 0.1 mg of fenoterol of an average particle size of < 6 µm and in Example 2, 0.04 mg of ipratropium bromide with an average particle size of <6 µm. “W' is the proportion of active substance delivered by inhalation as a percentage of the quantity contained in the mixture. (Col. 2., line 39-46).
Walker et al. teach the active agent(s) / active ingredient(s) (RPL554) can be micronized and combined with a suitable carrier to form a suspension of micronized particles of respirable size, where micronized is typically defined as having particles in which at least 90 % of the particles have a mass median diameter of less than 10 µm. (pg. 11, lines 30-32 to pg. 12, line 1).
Abbott-Banner teaches a composition comprising the active agent(s) / active ingredient(s) (RPL554) may be administered by inhalation using a nebulizer inhaler. The active agent(s) / active ingredient(s) can be micronized and combined with a suitable carrier to form a suspension of micronized particles of respirable size, where micronized is typically defined as having particles in which at least about 90% of the particles have a mass median diameter of less than about 10 µm. The term "mass median diameter" means the diameter such that half the mass of the particles is contained in particles with larger diameter and half is contained in particles with smaller diameter. (pg. 11, 1st par.).
With regard to claims 8 and 24, Arnold et al. teach the pharmaceutical composition including of fine and coarser excipient (Col. 1, lines 55-57). In Example 1 the mixture contains, of fenoterol and in Example 2, of ipratropium bromide. “W' is the proportion of active substance delivered by inhalation as a percentage of the quantity contained in the mixture. (Col. 2, lines 39-46). There are no other excipients in the composition besides the fine and coarse glucose and the active ingredient. So the total amount of the active ingredient particles, the coarse glucose particles and the fine glucose particles is total 100.0 wt% relative to the total weight of the dry powder pharmaceutical composition.
Walker et al. teach a micronized RPL554/ensifentrine combination (100 mg) is blended with milled lactose (25 g) (e.g., lactose in which not greater than about 85% of the particles have a mass median diameter (MMD) of about 60 µm to 90 µm and not less than 15% of the particles have a MMD of less than 15 µm). (pg. 40, lines 14-19). In this case total micronized RPL554/ensifentrine, coarse lactose and fine lactose particles is 100% relative to the total weight of the dry powder pharmaceutical composition.
With regard to claims 9-10 Walker et al. teach a micronized RPL554/ensifentrine combination (100 mg) is blended with milled lactose (25 g) (e.g., lactose in which not greater than about 85% of the particles have a mass median diameter (MMD) of about 60 µm to 90 µm and not less than 15% of the particles have a MMD of less then 15 µm). The contents of the blisters are administered using a dry powder inhaler (DPI). (pg. 40, lines 14-19). The pharmaceutical compositions are suitable for inhaled administration. The pharmaceutical composition may be for administration by dry powder inhaler (DPI) or metered-dose inhaler (MDI). (pg. 11, line 18-20).
With regard to claim 16,
“A method” in claim 16 is a preamble and is not considered in the claim since it is just an introduction.
Walker et al. teach as a combined PDE3/PDE4 inhibitor, RPL554/ensifentrine has both anti-inflammatory and broncho-dilatory activity and is useful in the treatment of respiratory disorders such as asthma and chronic obstructive pulmonary disease (COPD). (pg. 1, lines 16-18).
Abbott-Banner teaches RPL554/Ensifentrine is an active as a disease modifying agent for treating cystic fibrosis, and other diseases mediated by CFTR malfunction. The present invention provides a compound for use in treating or preventing conditions from cystic fibrosis, chronic obstructive pulmonary disease (COPD), asthma, mild pulmonary disease, bronchitis. (pg. 2nd, 2nd last and last par.).
Spargo et al. teach treatment of the human or animal body typically comprises the treatment or prevention of a disease’s condition selected from asthma, allergic asthma, hay fever, allergic rhinitis, bronchitis, emphysema, bronchiectasis, chronic obstructive pulmonary disease (COPD), adult respiratory distress syndrome (ARDS), steroid resistant asthma, severe asthma, pediatric asthma, cystic fibrosis, lung fibrosis, pulmonary fibrosis, interstitial lung disease, skin disorders, atopic dermatitis, psoriasis, ocular inflammation, cerebral ischemia, inflammatory diseases and auto-immune diseases. (pg. 11, lines 3-9)
With regard to claim 17,
“A method” in claim 17 is a preamble and is not considered in the claim since it is just an introduction.
Arnold et al. teach that in Example 1 the mixture contains fenoterol of an average particle size of <6 µm and in Example 2, of ipratropium bromide with an average particle size also of <6 µm. (Col. 2, lines 39-42). It means about 50% of API particles are less than 6 µm.
Spargo et al. teach the pharmaceutical formulation may be a liquid pharmaceutical composition suitable for administration by inhalation comprising a diluent and a suspension of particles of a salt of RPL554 as described herein. The suspended particles of the salt of RPL554 typically have a particle size distribution with a Dv50 (median particle size by volume) value of from about 0.2 µm to about 5 µm. (pg. 10, line 5-9). Dv50 means 50% of RPL554 particles for inhalation are the fine particle fraction of the ensifentrine particles. The resulting powder may instead have a particle size with a mass median aerodynamic diameter from about 2 µm to about 5 µm, for instance from 2.5 µm to about 4.5 µm. (pg. 8, lines 1-9).
Response to Arguments
Rejections of claim 1-4, 6-10, 16, 17, and 22-24
Applicant argues that ( 1) The cited references do not teach or suggest the recited dry powder pharmaceutical composition.
Arnold:
Instead of suggesting the subject matter of the claims, Arnold's teachings would have
directed a person of ordinary skill in the art to prepare a dry powder inhaler (DPI) formulation
comprising: ( 1) The cited references do not teach or suggest the recited dry powder pharmaceutical composition. (A) coarse particles around 35 μm in size (smaller than the 50 μm to 70 μm recited in claim l); (B) a higher weight percentage of fine lactose particles (from 10 to 50 wt%, compared to the 2.0 wt% to 7.5 wt% recited in claim l); and (C) a far lower loading of API (~2 wt% or lower, compared to the 3.5 wt% to 6.0 wt% recited in claim 1).
Applicant's arguments have been fully considered but they are not persuasive since the basis for 103 rejection is that no one reference has to teach all the claim limitations for an obviousness rejection and therefore several references are combined to render the claims obvious. One with ordinary skill in the art can learn from and select specific parts of several prior arts’ teachings before the effective filing date of the invention to achieve better outcome results even though some prior arts may teach more and may teach different things.
A dry powder inhaler formulation is one of many different dry powder pharmaceutical compositions. The preparation of the formulation includes the composition. Also, applicant recited in the SPEC, pg. 1, 1st par. “The invention also relates to a dry powder inhaler comprising the dry powder pharmaceutical composition.”
Applicant’s Claim 1: administration by inhalation comprising:
(i) ensifentrine particles;
(ii) coarse lactose particles having a Dv50 of from 50 μm to 70 μm; and
(iii) fine lactose particles having a Dv50 of from 5 μm to 10 μm,
wherein:
the fine lactose particles are present in an amount of from 2.0 wt% to 7 .5 wt% relative to
the total weight to the dry powder pharmaceutical composition; and
the ensifentrine particles are present in an amount of from 3.5 wt% to 6.0 wt% relative to
the total weight of the dry powder pharmaceutical composition.
Arnold teaches
Arnold et al. teach in order to control and optimize the amount of inhalable active substance released when drugs are administered as inhalation powders, the invention calls for the use of auxiliaries consisting of mixtures of coarser particles (average particle size >20 µm) and finer particles (average particle size <10 µm). (Abs). The active substance micronized into inhalable particles is combined with suitable quantities of a mixture of one or more physiologically acceptable excipients, one component of the excipient mixture having a mean particle size of less than about 10 µm and the other having a mean particle size greater than about 20 µm, the average particle size generally being preferably less than 80 µm. (Col. 1, lines 48-54), which are overlapping with the fine and coarse particle sizes that applicants claim. Pharmaceutically suitable and physiologically harmless excipients for inhalation purposes are known. Examples include disaccharides such as lactose; Lactose and glucose are preferred (Col. 2, lines 23-24, 26 & 30). The fine glucose particles are present in an amount of from 0-11% relative to the total weight to the dry powder pharmaceutical composition. The percentages are calculated from percentages of fine glucose particles in the dry powder composition including the drugs in Example 1, col. 2, lines 49-55). The 0-11% of fine particles are overlapped with the 2.0-7.5 wt% in claim 1, and 3.5-4.0 % in claim 2 that the applicants claim. Average particle size is D50. Arnold teaches lactose and glucose. It would be obvious for one of skills in the art to select glucose or lactose for dry particle formulation for inhaling. One with skill in the art, is known for solving the same problem, is represented with design choices, may modify the teachings of the prior arts until they can achieve better outcome results.
In the case where the claimed ranges "overlap, approaching and similar ranges or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985)
Arnold et al. do not teach the ensifentrine particles.
Walker et al. teach RPL554/ensifentrine (Abs). A micronized RPL554 combination is blended with milled lactose, in which coarse lactose particle having MMD of about 60 µm to about 90 µm and the fine particles have a MMD of less than 15 µm). (pg. 40, lines 14-16), which are overlapping with applicants’ claim 1-(ii) of Dv50 of from 50 µm to 80 µm and 1-(iii) of fine lactose particles having a Dv50 of from 5 µm to 10 µm, and claim 4 of coarse laclose particle having D50 55-65 µm. MMD is D50 value, also known as mass-median- diameter (MMD) is the diameter which divides the particles into two groups with equivalent weight / mass. Each sieve is weighed, and the volume of each fraction is calculated in percent by weight, providing a mass-related distribution.
Walker et al. do not teach percentage of ensifentrine particles within range of 3.5-6%.
Spargo et al. teach RPL554/ensifentrine and its salts, for inhalation.
A dry powder pharmaceutical composition may comprise from 0.2 to 5.0 wt% of a salt of RPL554.
Abbott-Banner teaches RPL554/ensifentrine, may be administered to by any acceptable route of inhaled, nasal. Administration by inhalation is preferred.
Applicant suggested that skilled person may use different active ingredients, different excipients, different particle sizes, different particle percentages to prepare a DPI formulation, based on the differences that Arnold, Walker, Spargo or Abbott-Banner teach as applicant pointed out in the arguments/remarks, as Walker do not teach ensifentrine, lactose; Walker teaches that "not less than 15 % of the particles have a MMD of less then 15 µm; Spargo only describes DPI formulations comprising 0.2 to 5.0 wt% of ensifentrine salt and Abbott-Banner describes a formulation of ensifentrine with dry lactose "having a particle size between about 1 µm and about 100 µm, which do not match applicant’s limitations in claims. However, even though each prior art may teach more and may teach different things, each prior art teaches applicant’s limitations recited in the claims listed above and the basis for 103 rejection is that no one reference has to teach all the claim limitations for an obviousness rejection and therefore several references’ teachings listed above, are combined to render the claims obvious, and a mere disclosure of alternatives in the prior art does not automatically teach away, since one with ordinary skill in the art can learn from and select specific parts of several prior arts’ teachings before the effective filing date of the invention, is known for solving the same problem and is represented with design choices, may modify the teachings of the prior arts until they can achieve better outcome results.
Applicant argues that (2) The claimed dry powder pharmaceutical composition provides unexpected results.
Lactose is an excipient used in dry powder formulations. Lactose blends comprising coarse and fine lactose are often used as they have reduced friction compared with single grades of lactose. This leads to less sticking and improved flowability during formulation manufacture.
It has been found that the use of the specific lactose blend as defined in claim 1 in combination with particles of ensifentrine provides a dry powder formulation that can deliver an increased FPF compared with formulations prepared using other lactose blends. Id., p. 2, 11. 9-13.
These advantages arise from the specific blend of coarse and fine lactose used in the formulation,
compared to other possible blends. This finding is confirmed in the examples described in
Applicant's specification.
Applicant's arguments have been fully considered but they are not persuasive since coarse and fine particles combination has been known in the inhale system. Arnold teaches In order to control and optimize the amount of inhalable active substance released when drugs are administered as inhalation powders, the invention calls for the use of auxiliaries consisting of mixtures of coarser particles (average particle size>20 µm) and finer particles (average particle
size-10 µm). (Abs).
Different proportions of excipients affect the proportion of active substance which can be delivered by inhalation. Glucose with an average particle size of 35 µm (GI) and of 5 µm (GII) or 8 µm (GITI) was used as excipient. The mixture of excipients with the active substance was packaged, in 5 mg portions, into conventional capsules for powder inhalation and delivered from these capsules using an apparatus according to DE-A-3345722.
In Example 1 the mixture contains, per capsule, 0.1 mg of fenoterol of an average particle size of <6 µm and in Example 2, 0.04 mg of ipratropium bromide with an average particle size of <6 µm. “W' is the proportion of active substance delivered by inhalation as a percentage of the quantity contained in the mixture. (Col. 2, lines 31-46). The results show higher proportion of active substance delivered by inhalation as a percentage of the finer excipients increased up to 16% in Example 1 and up to 50% in example 2.
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Arnold teaches that It is known to improve the properties of powdered inhalable preparations which are important in practice by combining the drug having an effective particle size of about
0.01-10 µm, (Col. 1, 2nd par.), which correlate with fine particle size, <10 µm, of excipient also. W% in Examples 1 and 2 that W is the proportion of fine active substance delivered by inhalation as a percentage of the quantity contained in the mixture. Arnold has proven the advantage of having fine carrier particle size.
In applicant’s Example 1, Table 2, Ensifentrine dose 2.5%, without fine lactose vs. Table 3, same Ensifentrine dose 2.5%, with fine lactose 3.7%, results of Emitted Dose ED do not show the advantage of having fine lactose over not having fine lactose. And Ensifentrine dose in Table 4 (pg. 13) 0.25% and 5, (pg. 14) 5 %, applicant’s results still do not show the advantage of ED with fine lactose % over ED without fine lactose. However, FPF data is more important.
In applicant’s Example 1, Table 2, Ensifentrine dose 2.5%, without fine lactose, FPF are varied from 48.4-38.5%, while Table 3, same Ensifentrine dose 2.5%, with fine lactose 3.7%, results of FPF are varied from 45-47%. With fine lactose, applicant’s results do not confirm the advantage of having fine lactose particles.
In Table 4, Ensifentrine dose 0.25%, FPF are without fine lactose 34.7% vs with fine lactose 35.8 and 31.8. These FPF do not show the advantage of having fine lactose.
In Table 5, Ensifentrine dose 5%, FPF are without fine lactose 46.9% vs with fine lactose 54.0 and 51.6. These FPF show the advantage of having fine lactose. However, these advantages are only for higher dose of Ensifentrine.
However, the results show higher FPF with fine lactose only depend on the higher dose of the drug, which do not confirm applicant unexpected results of the advantage of having high fine lactose %. Also applicant has FPF cut off at 5 µm, which is different from Arnold. Perhaps, if applicant has FPF cut off at 10µm, the results may be different. However, Arnold has proven the advantage of having fine carrier particle size.
Conclusion
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 extension fee 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 date of this final action.
Correspondence
No claim is allowed
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/NGOC-ANH THI NGUYEN/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
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