DETAILED ACTION
Status of Application
The response filed 11/14/2025 has been received, entered and carefully considered. The response affects the instant application accordingly:
Claims 1, 6-8, 12-13, 15-16, 19, 21 have been amended.
Applicant had previously elected Group I, claims 18-19 and 21 are withdrawn being drawn to a non-elected invention.
Claims 1-19 and 21 are pending.
Claims 1-17 are present for examination at this time.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant has made the statement that Luo (WO 2020/011254) which is also its national stage application of U.S. Pat. Pub. 2021/0323960 and was used as the translation of the WIPO document, along with the instant application were both subject to an obligation of assignment to Chia Tai Tianquing Pharmaceutical Group Co. Ltd. no later than the effective filing date of the claimed invention; wherein Luo no longer qualifies as prior art under 102(a)(2).
Applicant has also made a statement that the inventions of the present application were obtained directly from Luo who is an inventor in both the Luo referent and present application with the assertion that the Luo reference under 102(a)(1) is overcome which is not persuasive. Applicant has not provided a declaration under 37 CFR 1.130(a) to disqualify the prior art disclosure by establishing that the disclosure was made by the inventor or a joint inventor; or the subject matter disclosed; and accompanied by a reasonable explanation of the presence of additional authors (see MPEP 717.01(a)(1)). Wherein Luo et al. continues to qualifies as prior art under 102(a)(1).
However, Applicant has submitted an English translation of the certified priority documents along with a statement that the translation of the certified copy is accurate wherein the effective filing date of the claimed invention is now 01/15/2020 wherein Luo et al. no longer qualifies as prior art under 102(a)(1) and the rejections based on Luo et al. are withdrawn.
Applicant has stated that Yao et al. (WO 2021/143843) claims priority back to the same day of 1/15/2020 as the instant application wherein Yao was not effectively filed before the instant effectively filing date. This is not the case previously as addressed in the prior action where the effective filing date was the PCT filing date as there was no English translation of the foreign document to perfect the foreign priority. Applicant has however now submitted the English translation of the foreign priority document and also made the statement that Yao et al. and the instant application were both subject to an obligation of assignment to Chia Tai Tianquing Pharmaceutical Group Co. Ltd. no later than the effective filing date of the claimed invention; wherein Yao et al. no longer qualifies as prior art under 102(a)(2). The rejections based on Yao et al. are withdrawn.
New grounds of rejection are set forth in the current office action as a result of amendment.
Priority
Applicant has submitted an English translation of the certified priority documents along with a statement that the translation of the certified copy is accurate wherein the effective filing date of the claimed invention is now 01/15/2020.
New Grounds of Rejection
Due to the amendment of the claims the new grounds of rejection are applied:
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 3- 9, 11, 15-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 12 of U.S. Patent No. 11993596 in view of in view of Spargo et al. (WO 2016/042313).
The teachings of the patented claim is to the instant compound.
The patented claim does not expressly teach the compound in a formulation but it is prima facie obvious to place a compound in a formulation for use.
Spargo et al. teaches that RPL554 which is a known PD3/PD4 inhibitor
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(has the same central chemical core as the patented
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) useful for respiratory conditions such as asthma and COPD can be formulated as a liquid suspension pharmaceutical composition for inhalation comprising various excipients including surfactants, buffers for a preferred pH of about 6-about 8, tonicity agent (osmotic agent/osmogent), diluents, and other components (abstract, Page 1-3, Page 5 paragraph 4-Page 7). The surfactants include non-ionic surfactants such as polyoxyethylene glycol alkyl ether and polysorbates (polyoxyethylene glycol sorbitan alkyl esters) and mixtures of surfactants like a polysorbate and a Span surfactant, with the surfactants at a total concentration typically from about 0.01-about 2mg/ml; polysorbates are preferred like polysorbate 20 and polysorbate 80; buffers can be any pharmaceutical acceptable buffers including citrate like citric acid and sodium citrate and mixtures thereof, and phosphate buffers like dibasic sodium phosphate (also known as disodium hydrogen phosphate), monosodium phosphate (also known as sodium dihydrogen phosphate), phosphoric acid and mixtures thereof (Page 5 paragraph 5- Page 6). The tonicity/osmotic agent can be any pharmaceutically acceptable tonicity adjuster like sodium chloride and is typically from about 2-about 8mg/ml like about 3.5-6mg/ml (Page 6 last paragraph-Page 7 1st paragraph). The diluents include water, ethanol and glycerol the preferred diluent is water (Page 7). The drug particles have a median particle size by volume (Dv50) that is equal to or less than 10µm like about 0.1µm to about 8µm and present from about 0.01-about 40mg/mL like 0.1-5mg/ml (Page 4 paragraph 2-3, Page 5 paragraph 3) . A possible composition taught is
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where the diluent is preferably water
and
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where the diluent is preferably water (Page 7-8).
Wherein it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to formulate the patented compound
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which has the same chemical core as (which the specification can be used as a dictionary definition to determine its utility as a PDE3/PD4 inhibitor as it is a utility patent) in an inhalant suspension formulation with excipients as suggested by Spargo and produce the claimed invention; as it is prima facie obvious to formulate the compound (PDE3/PD4 inhibitor) in a known inhalant suspension composition for PDE3/PD4 inhibitors that also has the same chemical core with a reasonable expectation of success. Spargo et al. teaches the formulation with various excipients like buffers, surfactants, tonicity agents, diluents, and particle sizes (i.e. about 0.1µm to about 8µm) like
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wherein simple substitution of a known PDE3/PD4 inhibitor for another or the inclusion of another PDE3/PD4 inhibitor for its additive effect in the formulation at the recited concentration range for related RPL554 and to optimize within that range to attain the desired therapeutic profile with a reasonable expectation of success absent evidence of criticality for the claimed values. is prima facie obvious with a reasonable expectation of success. As amount of active can be from 0.05-25mg/ml was and the amount of surfactant is about 0.01-about 2mg/ml, the ratio is from about 0.025-2500- where it is prima facie obvious to optimize the amount of active and surfactant and arrive at the claimed ratio as a means of attaining the desired therapeutic profile with a reasonable expectation of success absent evidence of criticality for the claimed values.
Response to Arguments:
Applicant's arguments are centered on the assertion that the patented claims do not recite the specific surfactants claimed, that the composition claimed have good stability and various properties for effective delivery of inhalation produces like acceptable level of impurities, that Spargo are to compounds that are structurally different from the instant claimed compound and does not disclose the advantageous effects of the pharmaceutical composition, and that the patented claims share a common assignment with the claimed invention where is disqualified as prior art.
This is fully considered but not persuasive
Applicant's arguments against to the patented claims and to Spargo are to the patent and reference individually, and one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The patented claim is to the instant claimed compound and it is prima facie obvious to place a compound in a formulation for use and a compound must have a utility wherein the specification can be used as a dictionary to disclose the utility of PD3/PD4 inhibitor, and Spargo et al. teaches a known inhalant formulation wherein simple substitution of a known PDE3/PD4 inhibitor for another or the inclusion of another PDE3/PD4 inhibitor for its additive effect in the formulation at the recited concentration range for related RPL554 and to optimize within that range and the taught ranges for the excipient to attain the desired therapeutic profile with a reasonable expectation of success absent evidence of criticality for the claimed values. As the same components are present, the same properties would be expected to be present. The fact that Applicant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. As for the assertion that the patented claim is commonly assigned to the instant application, this is accurate and resolves Luo for no longer being prior art, but is the basis for the double patenting which is presented above.
Accordingly, the rejection stands.
Claims 2, 10 are rejected under 35 U.S.C. 103 as being unpatentable over claim 12 of U.S. Patent No. 11993596 in view of in view of Spargo et al. (WO 2016/042313) as applied to claims 1, 3-9, 11, 15-17 above, further in view of Mohsen et al. (U.S. Pat. Pub. 2010/0183725).
Rejection:
The teachings of the patented claim in view of Spargo et al. are addressed above.
The patented claim in view of Spargo et al. does not expressly teach the inclusion of a chelating agent but does teach the inclusion of excipients for the inhalant suspension.
Mohsen et al. teaches that inhalation formulations are known to contain additives including chelating agents (sequestrants) such as EDTA (edetic acid) [28].
Wherein it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate a chelator like EDTA in the composition suggested by Mohsen et al. and produce the claimed invention; as it would be prima facie obvious to incorporate known additives in inhalation formulations with a reasonable expectation of success.
Response to Arguments:
Applicant's arguments are to the patented claim in view of Spargo which are addressed above.
Accordingly, the rejection stands.
Claims 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over claim 12 of U.S. Patent No. 11993596 in view of in view of Spargo et al. (WO 2016/042313) and Mohsen et al. (U.S. Pat. Pub. 2010/0183725) as applied to claims 2, 10 above, further in view of Rowe et al. (Handbook of Pharmaceutical Excipients-Edetic Acid).
Rejection:
The teachings of patented claims in view of Spargo et al. and Mohsen et al. are addressed above.
The patented claim in view of Spargo et al. and Mohsen et al. does not expressly teach the amount of EDTA or for the EDTA to be the disodium salt (disodium edetate), but does teach the inclusion of chelators like EDTA.
Rowe et al. teaches that edetic acid (EDTA) has salts which are related substances like disodium edetate; and edetic acid and its edetate salts are used as chelators/sequestrant/antioxidants and are typically employed from 0.005-0.1%w/v (0.05-1mg/ml, items 6-7, 17).
Wherein it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the EDTA or its salt in its known range as suggested by Rowe et al. and produce the claimed invention; as it is prima facie obvious to utilize the EDTA or its related salt in its known range with a reasonable expectation of success.
Response to Arguments:
Applicant's arguments are to the patented claim in view of Spargo which are addressed above.
Accordingly, the rejection stands.
Claims 1, 3- 9, 11, 14-17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-5, 7-8, 10-11, 13, 15, 17-18, 21-22 of copending Application No. 17792192 in view of Spargo et al. (WO 2016/042313).
The teachings of the copending claims are to crystalline forms of the instant compound, copending claim 22 is to a pharmaceutical composition with the crystalline form of the compound.
The copending claims other than copending claim 22, do not expressly teach the compound in a formulation but it is prima facie obvious to place a compound in a formulation for use.
Spargo et al. teaches that RPL554 which is a known PD3/PD4 inhibitor
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(has the same central chemical core as the patented
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) useful for respiratory conditions such as asthma and COPD can be formulated as a liquid suspension pharmaceutical composition for inhalation comprising various excipients including surfactants, buffers for a preferred pH of about 6-about 8, tonicity agent (osmotic agent/osmogent), diluents, and other components (abstract, Page 1-3, Page 5 paragraph 4-Page 7). The surfactants include non-ionic surfactants such as polyoxyethylene glycol alkyl ether and polysorbates (polyoxyethylene glycol sorbitan alkyl esters) and mixtures of surfactants like a polysorbate and a Span surfactant, with the surfactants at a total concentration typically from about 0.01-about 2mg/ml; polysorbates are preferred like polysorbate 20 and polysorbate 80; buffers can be any pharmaceutical acceptable buffers including citrate like citric acid and sodium citrate and mixtures thereof, and phosphate buffers like dibasic sodium phosphate (also known as disodium hydrogen phosphate), monosodium phosphate (also known as sodium dihydrogen phosphate), phosphoric acid and mixtures thereof (Page 5 paragraph 5- Page 6). The tonicity/osmotic agent can be any pharmaceutically acceptable tonicity adjuster like sodium chloride and is typically from about 2-about 8mg/ml like about 3.5-6mg/ml (Page 6 last paragraph-Page 7 1st paragraph). The diluents include water, ethanol and glycerol the preferred diluent is water (Page 7). The drug particles have a median particle size by volume (Dv50) that is equal to or less than 10µm like about 0.1µm to about 8µm and present from about 0.01-about 40mg/mL like 0.1-5mg/ml (Page 4 paragraph 2-3, Page 5 paragraph 3) . A possible composition taught is
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where the diluent is preferably water
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where the diluent is preferably water (Page 7-8).
Wherein it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to formulate the patented compound
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which has the same chemical core as (which the specification can be used as a dictionary definition to determine its utility as a PDE3/PD4 inhibitor as it is a utility patent) in an inhalant suspension formulation with excipients as suggested by Spargo and produce the claimed invention; as it is prima facie obvious to formulate the compound (PDE3/PD4 inhibitor) in a known inhalant suspension composition for PDE3/PD4 inhibitors that also has the same chemical core with a reasonable expectation of success. Spargo et al. teaches the formulation with various excipients like buffers, surfactants, tonicity agents, diluents, and particle sizes (i.e. about 0.1µm to about 8µm) like
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wherein simple substitution of a known PDE3/PD4 inhibitor for another or the inclusion of another PDE3/PD4 inhibitor for its additive effect in the formulation at the recited concentration range for related RPL554 and to optimize within that range to attain the desired therapeutic profile with a reasonable expectation of success absent evidence of criticality for the claimed values. is prima facie obvious with a reasonable expectation of success. As amount of active can be from 0.05-25mg/ml was and the amount of surfactant is about 0.01-about 2mg/ml, the ratio is from about 0.025-2500- where it is prima facie obvious to optimize the amount of active and surfactant and arrive at the claimed ratio as a means of attaining the desired therapeutic profile with a reasonable expectation of success absent evidence of criticality for the claimed values.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments:
Applicant's arguments are centered on the assertion that the copending claims do not recite the specific surfactants claimed, that the composition claimed have good stability and various properties for effective delivery of inhalation produces like acceptable level of impurities, and that the copending claims share a common assignment with the claimed invention and has the same effective filing date where is disqualified as prior art.
This is fully considered but not persuasive
Applicant's arguments against to the copending claims individually, and one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The copending claim is to the instant claimed compound and it is prima facie obvious to place a compound in a formulation for use and a compound must have a utility wherein the specification can be used as a dictionary to disclose the utility of PD3/PD4 inhibitor, and Spargo et al. teaches a known inhalant formulation wherein simple substitution of a known PDE3/PD4 inhibitor for another or the inclusion of another PDE3/PD4 inhibitor for its additive effect in the formulation at the recited concentration range for related RPL554 and to optimize within that range and the taught ranges for the excipient to attain the desired therapeutic profile with a reasonable expectation of success absent evidence of criticality for the claimed values. As the same components are present, the same properties would be expected to be present. The fact that Applicant has recognized another advantage which would flow naturally from following the suggestion of the prior art for the copending claims cannot be the basis for patentability when the differences would otherwise be obvious. As for the assertion that the copending claims are commonly assigned to the instant application and has the same effective filing date, this is accurate and resolves it for no longer being prior art, but is the basis for the double patenting which is presented above.
Accordingly, the rejection stands.
Claims 2, 10 are provisionally rejected under 35 U.S.C. 103 as being unpatentable over claims 1-2, 4-5, 7-8, 10-11, 13, 15, 17-18, 21-22 of copending Application No. 17792192 in view of Spargo et al. (WO 2016/042313) as applied to claims 1, 3-9, 11, 14-17 above, further in view of Mohsen et al. (U.S. Pat. Pub. 2010/0183725).
Rejection:
The teachings of the copending claims in view of Spargo et al. are addressed above.
The copending claims in view of Spargo et al. does not expressly teach the inclusion of a chelating agent but does teach the inclusion of excipients for the inhalant suspension.
Mohsen et al. teaches that inhalation formulations are known to contain additives including chelating agents (sequestrants) such as EDTA (edetic acid) [28].
Wherein it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate a chelator like EDTA in the composition suggested by Mohsen et al. and produce the claimed invention; as it would be prima facie obvious to incorporate known additives in inhalation formulations with a reasonable expectation of success.
Response to Arguments:
Applicant's arguments are directed to the copending claims which are addressed above.
Accordingly, the rejection stands.
Claims 12-13 are provisionally rejected under 35 U.S.C. 103 as being unpatentable over claims 1-2, 4-5, 7-8, 10-11, 13, 15, 17-18, 21-22 of copending Application No. 17792192 in view of Spargo et al. (WO 2016/042313) and Mohsen et al. (U.S. Pat. Pub. 2010/0183725) as applied to claims 2, 10 above, further in view of Rowe et al. (Handbook of Pharmaceutical Excipients-Edetic Acid).
Rejection:
The teachings of copending claims in view of Spargo et al. and Mohsen et al. are addressed above.
The copending claims in view of Spargo et al. and Mohsen et al. does not expressly teach the amount of EDTA or for the EDTA to be the disodium salt (disodium edetate), but does teach the inclusion of chelators like EDTA.
Rowe et al. teaches that edetic acid (EDTA) has salts which are related substances like disodium edetate; and edetic acid and its edetate salts are used as chelators/sequestrant/antioxidants and are typically employed from 0.005-0.1%w/v (0.05-1mg/ml, items 6-7, 17).
Wherein it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the EDTA or its salt in its known range as suggested by Rowe et al. and produce the claimed invention; as it is prima facie obvious to utilize the EDTA or its related salt in its known range with a reasonable expectation of success.
Response to Arguments:
Applicant's arguments are directed to the copending claims which are addressed above.
Accordingly, the rejection stands.
Status of Claims with Regards to Prior Art
The claims are free of the prior art but are subject to the double patenting rejection presented above.
Conclusion
Claims 1-17 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 GIGI GEORGIANA HUANG whose telephone number is (571)272-9073. The examiner can normally be reached Monday-Thursday 9:00-5:00pm.
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/GIGI G HUANG/Primary Examiner, Art Unit 1613