DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 March 16, 2026 has been entered.
Previous Rejections
Applicant’s arguments, filed March 16, 2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Status
Claims 11 – 14 and 18 are cancelled.
Claim 2 is withdrawn.
Claims 1, 3 – 10, 15 – 17, and 19 – 22 are examined here-in.
Withdrawn Rejections
Applicant’s arguments that a person of ordinary skill in the art would not have a reasonable expectation of success to achieve the claimed drug to lipid ratio of tiotropium encapsulation within liposomes (Remarks pages 7 – 11) have been fully considered and are persuasive. Since the prior art combination of Hayes and Jauernig teaches liposomal encapsulation of drugs that are not tiotropium, with no examples or explicit remarks regarding the encapsulation of tiotropium meeting the claimed drug to lipid ratio, and drug encapsulation into liposomes is known in the art to be variable, depending on chemical structure and physiochemical properties, the 35 U.S.C. 103 rejection has been withdrawn.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 1, 3 – 10, 15 – 17, and 19 – 22 are rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement. The claims contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor at the time the application was filed, had possession of the claimed invention.
Claim 1 recites drugs tiotropium bromide, glycopyrrolate, umeclidinium bromide, aclidinium bromide, oxitropium bromide, and combinations thereof as drugs encapsulated in a sustained release liposomal bronchodilator composition that has a drug-to-phospholipid ratio of 0.1 to 1 mol/mol. The specification names tiotropium bromide, glycopyrrolate, umeclidinium bromide, aclidinium bromide, ipratropium bromide, oxitropium bromide, indacaterol, arformoterol, formoterol, olodaterol, salbutamol, salmeterol, and vilanterol as bronchodilators (paragraphs 0049 – 0050). Tiotropium bromide, glycopyrrolate, indacaterol maleate, and salbutamol hemisulfate are included in Table 1 on page 18 of the instant specification. Tiotropium bromide, glycopyrrolate, indacaterol maleate, and salbutamol hemisulfate have drug-to-phospholipid ratios between 0.1 and 1 mol/mol and appear to meet the written description and enablement provisions of 35 U.S.C. 112(a).
However, claim 1 recites drugs tiotropium bromide, glycopyrrolate, umeclidinium bromide, aclidinium bromide, oxitropium bromide, and combinations thereof, which are all quaternary ammonium muscarinic antagonists but have various physicochemical characteristics and differing structures. The differing structures are shown below.
Claimed
Table 1 of Specification
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59
300
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Greyscale
Tiotropium
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59
300
media_image1.png
Greyscale
Tiotropium
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media_image2.png
97
177
media_image2.png
Greyscale
Glycopyrrolate
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media_image2.png
97
177
media_image2.png
Greyscale
Glycopyrrolate
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media_image3.png
249
165
media_image3.png
Greyscale
Umeclidinium
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media_image4.png
276
123
media_image4.png
Greyscale
Aclidinium
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media_image5.png
195
225
media_image5.png
Greyscale
Oxitropium
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media_image6.png
128
186
media_image6.png
Greyscale
Indacaterol
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media_image7.png
149
107
media_image7.png
Greyscale
Salbutamol
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media_image6.png
128
186
media_image6.png
Greyscale
PNG
media_image7.png
149
107
media_image7.png
Greyscale
Umeclidinium bromide, aclidinium bromide, oxitropium bromide, and combinations of the claimed drugs do not meet the written description provision of 35 U.S.C. 112(a) due to their vastly different chemical structures and physicochemical properties which may or may not lead to a differing drug-to-phospholipid ratio from that which is instantly claimed. For umeclidinium bromide, aclidinium bromide, oxitropium bromide, and combinations of the claimed drugs, there is factual uncertainty undermining the specificity of the invention, i.e. there does not appear to be any supporting evidence that the inventor was in possession of the invention at the time of filing. Gomez (Gomez, et al. “Liposomal nanovesicles for efficient encapsulation of staphylococcal antibiotics” ACS OMEGA, 2019, 4, 10866 – 10876, this document is also referred to as Exhibit B in Applicant’s Remarks dated February 17, 2026) discloses that liposome and drug cargo compatibility is highly dependent on the physicochemical characteristics of the drug, the choice of liposome components, and the encapsulation technique (page 10866 column 2) thus suggesting that different drug cargos will have differing encapsulation and drug-to-phospholipid ratios that vary with their structure and physicochemical properties. Due to the significantly different structures and physicochemical characteristics of umeclidinium bromide, aclidinium bromide, oxitropium bromide, and combinations of the claimed drugs, from the drugs described in Table 1, it is not clear that the inventor was in possession of the invention (umeclidinium bromide, aclidinium bromide, oxitropium bromide in drug-to-phospholipid ratios as claimed) at the time of filing. According to MPEP 2163(ii)((3)(i), “reduction to practice in effect provides the only evidence to corroborate conception (and therefore possession) of the invention”.
Conclusion
The 35 U.S.C. 103 prior art rejection has been withdrawn.
Claims 1, 3 – 10, 15 – 17, and 19 – 22 are rejected under 35 U.S.C. 112(a).
All claims are rejected. No claims are allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Toriana N. Vigil whose telephone number is (571)270-7549. The examiner can normally be reached Monday - Friday 9:00 a.m. - 5:00 p.m. EST.
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/TORIANA N. VIGIL/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
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