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 .
Election/Restrictions
Applicant's election with traverse of group I, claims 1-14 in the reply filed on 10/27/25 is acknowledged. The traversal is on the ground(s) that the prior art used to break unity does not teach that their composition is stable. This is not found persuasive because firstly applicants have not defined stable in any specific way, thus if the composition cited in the restriction requirement is stable for even 1 femtosecond it would read on those claims. Additionally, applicants argue that the restriction is not proper because the CN document cited in the restriction requirement does not have ethanol in the composition. The examiner respectfully points out that this wasn’t required at the time the restriction was made, and that further the amended claims are still obvious when taken in view of the documents cited in the 103 rejection below and as such the claims still lack a special technical feature in light of the obviousness rejection presented below and as such the restriction requirement is still proper and is maintained.
The examiner acknowledges applicant’s request for rejoinder.
The requirement is still deemed proper and is therefore made FINAL.
Claims 15-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected packaged pharmaceutical product wherein all of the limitations are directed to the packaging materials and how the packaging is sealed, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 10/27/25.
Specification
The use of the term Tween 80, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
The examiner also respectfully asks for applicants cooperation in identifying and correcting any other instances where trade names/trademarks are used in applicants specification.
Claim Objections
Claims 1-2, 4-5, and 13-14 are objected to because of the following informalities: Kuding, Kudinoside, Ilekudinoside, etc. are not proper nouns and should not be capitalized in the claims.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 is indefinite because it recites an “effective amount” but does not claim/recite the function that the effective amount is effective for and the specification teaches that the compositions are to be useful for treating COPD, asthma and potentially other lung diseases in which the effective amount for treating COPD is likely different than the effective amount for asthma, which is a different effective amount than that used to treat bronchitis, etc. The phrase "an effective amount" has been held to be indefinite when the claim fails to state the function which is to be achieved and more than one effect can be implied from the specification or the relevant art. In re Fredericksen, 213 F.2d 547, 102 USPQ 35 (CCPA 1954) see MPEP 2173.05 (c) III. In the instant case both the specification and claims recite multiple different lung diseases/illnesses which can be treated/controlled with the claimed active agents and as such the effective amounts are unclear because the effective amounts for treating COPD are likely very different from the effective amounts for treating bronchitis, etc.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, Claims 2-8, 10-12 all contain broad ranges together with a narrow range or limitation that falls within the broad range or limitation (in the same claim). For example, claim 2 recites the broad recitation “R1 is a sugar residue”, and the claim also recites “preferably a monosaccharide residue or an oligosaccharide residue” which is the narrower statement of the range/limitation. All of the claims with this language are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
As there are many instances of preferably, more preferably, even more preferably, most preferably, etc. in the claims which invoke these broad ranges or limitations together with a narrow ranges or limitations are indefinite for the above reasons. The examiner respectfully asks for applicant’s assistance in ensuring that all instances of this type of language are addressed and/or corrected in applicant’s next response.
Claims 11, 13-14 contain the trademark/trade name TWEEN/TWEEN 80. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe polysorbates/polysorbate 80 and, accordingly, the identification/description is indefinite.
Claim 9 is also indefinite because it depends from claim 1 and does not resolve the ambiguities of that claim.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-14 is/are rejected under 35 U.S.C. 103 as being unpatentable CN106420852A (‘852), and further in view of CN103893165 and CN104208160, and as evidenced by Tang et al. (J. Nat. Prod., 2005, 68, 1169-1174) and JP6426752.
Determination of the scope and content of the prior art
(MPEP 2141.01)
Regarding claims 1-6, ‘852 teaches liquid pharmaceutical compositions comprising aqueous ethanol solutions and therapeutically effective amounts of a kuding saponin compound which is isolated from the same plant species instantly claimed via ethanol extraction, i.e. ilex cornut Lindl., ilex kudincha C. J. Tseng, ilex rotunda Thunb., specifically an inhalation solution or inhalation suspension, which pharmaceutically acceptable carrier comprising water and alcohol/ethanol (See entire document; Background of invention section; Paragraph beginning: “The purpose of this invention is achieved…Selecting raw materials…”; Example 6; The preparation of aerosol-on Kuding tea section; The preparation of Spray-on Kuding tea; abstract). ‘852 does not specifically teach what kuding saponin compound(s) are isolated via their ethanol extraction, but these ethanol extractions, specifically of ilex kudincha C. J. Tseng, clearly include Kudinoside-A, Kudinoside-D, etc. as is evidenced by Tang (See entire document; abstract; pg. 1173, left col. paragraph immediately before Experimental section heading). ‘852 teaches in their paragraph describing the preparation of Aerosol Folium Illicis that they use different amounts of Kuding tea (extract) with 5g of distilled water and 150 g, anhydrous ethanol were prepared to provide from 0.05-5 mg/spray (equivalent to a liquid concentration of 0.5-50 mg/mL) (See entire document; Background of invention section; Paragraph beginning: “The purpose of this invention is achieved…Selecting raw materials…”; Example 6; The preparation of aerosol-on Kuding tea section; The preparation of Spray-on Kuding tea; abstract). The solution was poured into containers at room temperature, the valve was installed and sealed, and then a quantitative amount of HFA-134a was injected using a press-filling machine (See entire document; Background of invention section; Paragraph beginning: “The purpose of this invention is achieved…Selecting raw materials…”; Example 6; The preparation of aerosol-on Kuding tea section; The preparation of Spray-on Kuding tea; abstract).
Regarding claims 7 and 10, ‘852 teaches in their paragraph describing the preparation of Aerosol Kuding Tea that they use different amounts of Kuding tea (extract) with 5g of distilled water and 150 g, anhydrous ethanol were prepared to provide from 0.05-5 mg/spray (equivalent to a liquid concentration of 0.5-50 mg/mL). The solution was poured into containers at room temperature, the valve was installed and sealed, and then a quantitative amount of HFA-134a was injected using a press-filling machine. It would be obvious to optimize the amounts of the Kuding saponin in the Kuding tea of ‘852 to fall within the claimed range of 0.001-0.050% by mass based on the total mass of the liquid pharmaceutical composition as claimed because ‘852 teaches using the same active agents for treating cough and pulmonary diseases (See entire document; Background of invention section; Paragraph beginning: “The purpose of this invention is achieved…Selecting raw materials…”; Example 6; The preparation of aerosol-on Kuding tea section; The preparation of Spray-on Kuding tea; abstract) and as is evidenced by JP6426752 it was known to treat pulmonary diseases, specifically COPD with the Kuding saponins/Kuding teas of ‘852, specifically Kudinosides A, D, etc. (See entire document; paragraph beginning: In order to test the therapeutic effect of a single substance in bitterling tea extract on asthma, two volunteers (51-year-old male, 72-year-old male)…; paragraphs discussion Figures, e.g. fig. 4, fig. 6, fig. 7, fig. 8, etc.; Paragraphs after (Relaxation effect of kudinoside on asthmatic contraction of animals) discussing effects of Kudinosides; Section: paragraph beginning with: In one embodiment, the compounds of formula (I) may be used for the treatment of lung disease. In certain embodiments, the compound of Formula (I) is in a pharmaceutically acceptable carrier. In one embodiment, the disease is a lung disease comprising at least one of asthma, COPD, bronchitis, chronic or acute bronchoconstriction, adult respiratory distress syndrome, acute lung injury and bronchiectasis. In one embodiment, the lung disease may include asthma and COPD. And paragraphs discussing COPD and asthma following; Claims).
Ascertainment of the difference between prior art and the claims
(MPEP 2141.02)
Regarding claims 1-14, ‘852 does not teach wherein the composition comprises a buffer having the claimed pH, specifically the claimed disodium hydrogen phosphate-potassium dihydrogen phosphate buffer of instant claims 8, 13-14 or wherein the composition further comprises the claimed cosolvent and/or stabilizer of instant claim 9, specifically Tween 80 (instant claim 11) and/or disodium edetate (instant claim 12) in the claimed amounts/mass% (claims 11-14). However, these deficiencies in ‘852 (as evidenced by Tang) are addressed by CN103893165 and CN104208160.
CN103893165 teaches formulations/compositions for inhalation for treating lung diseases, specifically asthma and COPD, which comprise the claimed buffer/buffer system comprising disodium hydrogen phosphate-potassium dihydrogen phosphate having a pH of 7.0 (See Examples 3 and 4; technical field section; paragraph beginning: The nebulized inhalant of the present invention may be formed into a medicament vapor, mist or aerosol…).
CN104208160 teaches other aerosol formulations for delivery by breathing/inhalation which comprise aqueous ethanol solutions (300 mL at 0.789 g/mL of ethanol (236.7 g) and 300 ml of water solution at ~1 g/ml containing 0.5% of disodium edetate= 1.5 g of disodium edetate and ~298.5 g of water, which would be about 0.25% by mass/weight of the final mixture (1.5/587.7 g) which is very close to the claimed 0.2 mass% claimed, Tween 80 (10 g, 10/587.7= 1.7% by mass/weight) and 1g butylated hydroxytoluene (Example 7).
Finding of prima facie obviousness
Rationale and Motivation (MPEP 2142-2143)
It would have been obvious to one of ordinary skill in the art at the time of the instant filing to have included the claimed buffer, specifically the combination of disodium hydrogen phosphate-potassium dihydrogen phosphate having a pH of 7.0, with the claimed cosolvents, solubilizers, e.g. Tween 80 and disodium edetate, into the compositions of ‘852 in order to develop the claimed formulations/compositions because each of the claimed agents was known to be useful for effectively formulating inhalation aerosols for treating lung/pulmonary diseases, specifically asthma and/or COPD. Thus, it would be obvious to combine known effective components for forming inhalation aerosol compositions for treating COPD and asthma in order to form new/effective inhalation aerosol compositions for treating COPD and asthma because, "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
It would have been obvious to one of ordinary skill in the art at the time of the instant filing to have optimized the amounts of ethanol, tween-80 and disodium edetate and in the inhalation aerosol formulations taught by the combined prior art in order to form the claimed compositions having the specific components in the instantly claimed amounts because it was known to use ethanol, tween-80 and disodium edetate for forming inhalation/aerosol compositions for effectively delivering active agents by breathing/inhalation, and “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. ‘[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.’" In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding the claimed stable limitation, applicants have not defined stable in any specific way, and this stability is a result effective property of forming the claimed composition which is rendered obvious by the prior art as discussed above and as such would result from forming the claimed obvious composition especially since as long as the composition is stable for even the smallest period of time it reads on the instant claim limitation as the claim is currently written.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the above claims would have been obvious to one of ordinary skill in the art within the meaning of 35 USC 103(a).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
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 1-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 10786521 in view of CN106420852A (‘852), CN103893165, and CN104208160, and as evidenced by Tang et al. (J. Nat. Prod., 2005, 68, 1169-1174) and JP6426752.
‘521 teaches methods of treating pulmonary diseases with compositions comprising the claimed extracts/Kudinoside A, etc. and wherein these compositions/formulations used in their methods are in inhalation forms with pharmaceutically acceptable carriers. ‘521 does not claim or disclose the specifically claimed stable formulations comprising the claimed amounts of ethanol, buffer, co-solvents, etc. e.g. sodium edetate and/or Tween 80 etc. that are instantly claimed. However, these deficiencies are addressed by ‘852 and the other secondary and evidentiary references cited above.
Regarding claims 1-6, ‘852 teaches liquid pharmaceutical compositions comprising aqueous ethanol solutions and therapeutically effective amounts of a kuding saponin compound which is isolated from the same plant species instantly claimed via ethanol extraction, i.e. ilex cornut Lindl., ilex kudincha C. J. Tseng, ilex rotunda Thunb., specifically an inhalation solution or inhalation suspension, which pharmaceutically acceptable carrier comprising water and alcohol/ethanol (See entire document; Background of invention section; Paragraph beginning: “The purpose of this invention is achieved…Selecting raw materials…”; Example 6; The preparation of aerosol-on Kuding tea section; The preparation of Spray-on Kuding tea; abstract). ‘852 does not specifically teach what kuding saponin compound(s) are isolated via their ethanol extraction, but these ethanol extractions, specifically of ilex kudincha C. J. Tseng, clearly include Kudinoside-A, Kudinoside-D, etc. as is evidenced by Tang (See entire document; abstract; pg. 1173, left col. paragraph immediately before Experimental section heading). ‘852 teaches in their paragraph describing the preparation of Aerosol Folium Illicis that they use different amounts of Kuding tea (extract) with 5g of distilled water and 150 g, anhydrous ethanol were prepared to provide from 0.05-5 mg/spray (equivalent to a liquid concentration of 0.5-50 mg/mL) (See entire document; Background of invention section; Paragraph beginning: “The purpose of this invention is achieved…Selecting raw materials…”; Example 6; The preparation of aerosol-on Kuding tea section; The preparation of Spray-on Kuding tea; abstract). The solution was poured into containers at room temperature, the valve was installed and sealed, and then a quantitative amount of HFA-134a was injected using a press-filling machine (See entire document; Background of invention section; Paragraph beginning: “The purpose of this invention is achieved…Selecting raw materials…”; Example 6; The preparation of aerosol-on Kuding tea section; The preparation of Spray-on Kuding tea; abstract).
Regarding claims 7 and 10, ‘852 teaches in their paragraph describing the preparation of Aerosol Kuding Tea that they use different amounts of Kuding tea (extract) with 5g of distilled water and 150 g, anhydrous ethanol were prepared to provide from 0.05-5 mg/spray (equivalent to a liquid concentration of 0.5-50 mg/mL). The solution was poured into containers at room temperature, the valve was installed and sealed, and then a quantitative amount of HFA-134a was injected using a press-filling machine. It would be obvious to optimize the amounts of the Kuding saponin in the Kuding tea of ‘852 to fall within the claimed range of 0.001-0.050% by mass based on the total mass of the liquid pharmaceutical composition as claimed because ‘852 teaches using the same active agents for treating cough and pulmonary diseases (See entire document; Background of invention section; Paragraph beginning: “The purpose of this invention is achieved…Selecting raw materials…”; Example 6; The preparation of aerosol-on Kuding tea section; The preparation of Spray-on Kuding tea; abstract) and as is evidenced by JP6426752 it was known to treat pulmonary diseases, specifically COPD with the Kuding saponins/Kuding teas of ‘852, specifically Kudinosides A, D, etc. (See entire document; paragraph beginning: In order to test the therapeutic effect of a single substance in bitterling tea extract on asthma, two volunteers (51-year-old male, 72-year-old male)…; paragraphs discussion Figures, e.g. fig. 4, fig. 6, fig. 7, fig. 8, etc.; Paragraphs after (Relaxation effect of kudinoside on asthmatic contraction of animals) discussing effects of Kudinosides; Section: paragraph beginning with: In one embodiment, the compounds of formula (I) may be used for the treatment of lung disease. In certain embodiments, the compound of Formula (I) is in a pharmaceutically acceptable carrier. In one embodiment, the disease is a lung disease comprising at least one of asthma, COPD, bronchitis, chronic or acute bronchoconstriction, adult respiratory distress syndrome, acute lung injury and bronchiectasis. In one embodiment, the lung disease may include asthma and COPD. And paragraphs discussing COPD and asthma following; Claims).
CN103893165 teaches formulations/compositions for inhalation for treating lung diseases, specifically asthma and COPD, which comprise the claimed buffer/buffer system comprising disodium hydrogen phosphate-potassium dihydrogen phosphate having a pH of 7.0 (See Examples 3 and 4; technical field section; paragraph beginning: The nebulized inhalant of the present invention may be formed into a medicament vapor, mist or aerosol…).
CN104208160 teaches other aerosol formulations for delivery by breathing/inhalation which comprise aqueous ethanol solutions (300 mL at 0.789 g/mL of ethanol (236.7 g) and 300 ml of water solution at ~1 g/ml containing 0.5% of disodium edetate= 1.5 g of disodium edetate and ~298.5 g of water, which would be about 0.25% by mass/weight of the final mixture (1.5/587.7 g) which is very close to the claimed 0.2 mass% claimed, Tween 80 (10 g, 10/587.7= 1.7% by mass/weight) and 1g butylated hydroxytoluene (Example 7).
It would have been obvious to one of ordinary skill in the art at the time of the instant filing to have included the claimed buffer, specifically the combination of disodium hydrogen phosphate-potassium dihydrogen phosphate having a pH of 7.0, with the claimed cosolvents, solubilizers, e.g. Tween 80 and disodium edetate, into the liquid compositions taught by the combination of ‘521 and ‘852 in order to develop the claimed formulations/compositions because each of the claimed agents was known to be useful for effectively formulating inhalation aerosols for treating lung/pulmonary diseases, specifically asthma and/or COPD. Thus, it would be obvious to combine known effective components for forming inhalation aerosol compositions for treating COPD and asthma in order to form new/effective inhalation solution aerosol compositions for treating COPD and asthma because, "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
Regarding the claimed stable limitation, applicants have not defined stable in any specific way, and this stability is a result effective property of forming the claimed composition which is rendered obvious by ‘521 and the prior art as discussed above and as such would result from forming the claimed obvious composition especially since as long as the composition is stable for even the smallest period of time it reads on the instant claim limitation as the claim is currently written.
It also would have been obvious to one of ordinary skill in the art at the time of the instant filing to have optimized the amounts of ethanol, tween-80 and disodium edetate, etc. as claimed in the inhalation solution aerosol formulations taught by ‘521 and the combined references of the prior art in order to form the claimed compositions having the specific components in the instantly claimed amounts because it was known to use ethanol, tween-80 and disodium edetate for forming inhalation/aerosol compositions for effectively delivering active agents by breathing/inhalation, and “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. ‘[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.’" In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Especially since the claimed agent were already known in the art to be useful for treating COPD, etc. and were all known to effective for formulating inhalation aerosol formulations and as such it would be obvious to optimize these known components in order to form the most effective Kuding extract/Kudinoside A composition for treating COPD, etc.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the above claims would have been obvious to one of ordinary skill in the art within the meaning of 35 USC 103(a).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Claims 1-14 are also rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10046004 in view of CN106420852A (‘852), CN103893165, and CN104208160, and as evidenced by Tang et al. (J. Nat. Prod., 2005, 68, 1169-1174) and JP6426752 for the same and/or similar reasons which are discussed above with respect to ‘521.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Erin E Hirt whose telephone number is (571)270-1077. The examiner can normally be reached 10:30-7:30 ET M-F.
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/ERIN E HIRT/Primary Examiner, Art Unit 1616 ---