DETAILED ACTION
Claims 1-2, 4-6, 9, 16, 18-19, 22, 24, 28, 34, 36, 41, 48-53, 55-56, 58, 61, 65, 73, 75, 77, 81, 85, 90, 95, 97, 104, 113, 131-132, 142, 147, 149, 156, 158, 165, 167, 171, 173-179, 187-189 and 211 are currently pending. Claims 1-2, 4-5, 16, 18-19, 22, 24, 36, 41, 48-50, 55-56, 58, 61, 65, 73, 75 and 81 are currently under examination.
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 without traverse of Group I in the reply filed on 06/02/2026 is acknowledged.
Claims 85, 90, 95, 97, 104, 113, 131-132, 142, 147, 149, 156, 158, 165, 167, 171, 173-179, 187-189 and 211 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06/02/2026.
Applicant’s election without traverse of poly(lactic-co-glycolic acid) (PLGA), leucine, administration to lungs in the form of an inhalable particle, polyethylene glycol pore forming agent, corticosteroids as an anti-inflammatory, lung disease in the reply filed on 06/02/2026 is acknowledged.
Claim 6, 9, 28, 34, 51-53 and 77 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06/02/2026.
Priority
The instant invention is a national stage entry of PCT/US2022/052972, filed 12/15/2022, which claims priority to provisional application 63/290297, filed 12/16/2021.
Information Disclosure Statement
Applicant’s Informational Disclosure Statement, filed on 06/06/2024 and 02/25/2026 has been considered. Please refer to Applicant's copy of the 1449 submitted herein.
Specification
The specification amendments submitted 01/23/2025 are entered.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-2, 4-5, 16, 19, 22, 36, 41, 48-49, 56, 65, 75 and 81 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Takeuchi (Takeuchi, Issei, et al, Colloids and Surfaces A 537 (2018) pgs 411-417).
Regarding claims 1, 16, 19, 22, the limitation of a pharmaceutical composition comprising a lactic acid producing compound selected from a group including a polymeric compound that can produce lactic acid and a pharmecuatially acceptable excipient, wherein the pharmaceutical compristion is formulated for administration to the lungs or for oral administration is met by Takeuchi teaching the elected leucine and PLGA microparticles for pulmonary administration (title, abstract).
Regarding claim 2, the limitation of wherein the pharmaceutical composition is formulated for administration to the lungs by inhalation is met by Takeuchi teaching the drug delivered deep into the lung (page 412, first column, first paragraph) with dry powder inhaler (page 412, second column, last paragraph).
Regarding claims 4-5, 65, 75, the limitation of wherein the lactic-acid producing compound produces lactic acid upon delivery to a target tissue, wherein the target tissue is a target bronchopulmonary tissue and delivered dose of at least 25% to at most 125% of the pharmaceutical composition by mass to a target tissue is met by the Takeuchi teaches the elected PLGA with pulmonary administration (title, abstract) and thus capable of bronchopulmonary tissue and delivered dose absent factual evidence to the contrary.
Regarding claim 36 and 41, the limitation of further comprising at least one including pH modulating agent, at least one acid generating molecule is not lactic acid is met by Takeuchi teaching aspartic acid (Table 1).
Regarding claims 48-49, the limitation of further comprising at least one additional therapeutic for chronic or infectious bronchopulmonary disorder is met by Takeuchi teaching rifampin (abstract), wherein the instant specification evidence rifampin as an exemplary antimicrobial [0313].
Regarding claims 56, 58, the limitation of wherein the pharmaceutical composition is formulated as a microsphere is met by Takeuchi teaching microspheres made through spray drying wherein they are freeze dried (page 412, second column, first paragraph).
Regarding claim 81, the limitation of wherein the pharmaceutical compristion is formulated for delivery by a dry powder inhaler, a metered dose inhaler or a soft mist inhaler is met by Takeuchi teaching the elected leucine and PLGA microparticles for pulmonary administration (title, abstract). As Takeuchi teaches the structural features of the instant claim the compristion could be capable of delivery e.g. through dry powder inhaler, absent factual evidence to the contrary.
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) 1-2, 4-5, 16, 18-19, 22, 24, 36, 41, 48-50, 56, 58, 61, 65, 75 and 81 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2004/0105821 in view of Takeuchi.
Regarding claims 1 and16, the limitation of a pharmaceutical composition comprising a lactic acid-producing compound selected from a polymeric compound that can produce lactic acid and a pharmaceutically acceptable excipient wherein the pharmaceutical compristion is formulated for administration to the lungs or for oral administration is met by the ‘821 publication teaching pharmaceutical formulations for delivery to the lungs of a patient by inhalation. The formation includes porous microparticles comprise a pharmaceutical agent and a matrix material. The pharmaceutical ingredient is taught to be corticosteroid (abstract). The matrix material is taught to include a polymer, a hydrophobic small molecule or a combination thereof, wherein the polymer includes PLGA [0013]. Suitable hydrophobic compounds are taught to include leucine [0073].
Regarding claim 2, the limitation of wherein the composition is formulated for administration to the lungs by inhalation is met by the ‘821 publication teaching powder inhaler [0171].
Regarding claims 4, 65 and 75, the limitation of wherein the lactic acid producing compound produces lactic acid upon delivery to a target tissue, wherein the target tissue is a target bronchopulmonary tissue is met by the ‘821 publication teaching pharmaceutical formulations for delivery to the lungs of a patient by inhalation. The formation includes porous microparticles comprise a pharmaceutical agent and a matrix material. The pharmaceutical ingredient is taught to be corticosteroid (abstract). The matrix material is taught to include a polymer, a hydrophobic small molecule or a combination thereof, wherein the polymer includes PLGA [0013]. Thus the ‘821 publication teaches the elected compound, PLGA, and delivery to the lungs and thus would be capable of lactic acid production upon delivery to a target tissue and delivered dose, absent factual evidence to the contrary.
Regarding claim 5, the limitation of wherein the target bronchopulmonary tissue is the lungs, the trachea, the bronchi, the bronchioles and/or the alveoli is met by the ‘821 publication teaches delivery to the tracheobronchial tree [0052].
Regarding claim 18, the limitation of wherein the pharmaceutical composition comprises at least 1% of a lactic acid producing compound by weight is met by the ‘821 publication teaching the matrix material is present at least 5% w/w [0063].
Regarding claim 19, 22 and 24, the limitation of at least one excipient, leucine, at least 5% excipient by weight is met by the ‘821 publication teaching the elected leucine, wherein matrix material is at least 5% w/w of the microparticle, wherein a combination of polymer and hydrophobic material is taught ([0063], [0073], [0013]).
Regarding claim 36, further comprising at least one pore forming agent is met by the ‘821 publication teaching at least one pore forming agent [0024].
Regarding claim 41, the limitation of further comprising at least one acid-generating molecule that can generate acid wherein the at least one acid generating molecule is not lactic acid or does not comprise lactic acid is met by the ‘821 publication teaching free acid or salt form including citric acid and citrate [0077].
Regarding claims 48-50, the ‘821 publication teaches the elected corticosteroid ([0133], claim 8).
Regarding claim 56, the limitation of wherein the pharmaceutical composition is formulated as microspheres is met by the ‘821 publication teaching microspheres [0056].
Regarding claim 58, the limitation of wherein the pharmaceutical compristion comprises a plurality of dried particles by the ‘821 publication teaching dry powder [0079].
Regarding claim 61, the limitation of wherein the dried particles has a medium mass aerodynamic diameter (MMAD) of at most 5 um is met by the ‘821 publication teaching a volume medium diameter of between 1um and 5um (claim 5) wherein the diameter determines the delivery area [0052]. As MPEP 2144.05 recites “where 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 optimization”.
Regarding claim 81, the limitation of wherein the pharmaceutical compristion is formulated for delivery by a dry powder inhaler, a metered dose inhaler or a soft mist inhaler is met by the ‘821 publication teaching dry powder inhalation device [0079], thus the dry powder is capable of being delivered by a dry powder inhaler, absent factual evidence to the contrary.
The ’821 publication teaches the elected PLGA and leucine, however does not exemplify them used in combination.
Takeuchi teaching nanocomposite particle preparation method using amino acid to microparticle for inhalation, the influence of L-leucine on small fine particle fraction values of poly(lactic-co-glycolide) (PLGA) microparticles, which are active agent loaded (abstract, 2.1, Table 1). Leucine is taught to have the effect of reducing the aggregability of the particles (page 412, first column, second paragraph).
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use the combination of PLGA and leucine in the particles taught by the ‘821 publication as the ‘821 publication teaches the particles may be formed of a combination of matrix compounds that include PLGA and leucine and Takeuchi specifically exemplifies the combination of PLGA and leucine. One of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success as the ‘821 publication and Takeuchi both are directed to dry particles for drug delivery to the lungs which include PLGA and leucine. One of ordinary skill in the art before the filing date of the claimed invention would be motivated to use the combination of PLGA and leucine as Takeuchi teaches the particles to not aggregate.
Claim(s) 55 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2004/0105821 and Takeuchi as applied to claims 1-2, 4-5, 16, 18-19, 22, 24, 36, 41, 48-50, 56, 58, 61, 65, 75 and 81 above, and further in view of US20170014341.
As mentioned in the above 103 rejection, all of the limitations of claims 1-2, 4-5, 16, 18-19, 22, 24, 36, 41, 48-50, 56, 58, 61, 65, 75 and 81 are taught by the combination of the ‘821 publication and Takeuchi.
The combination of references does not specifically teach a bolus dose of lactic acid (claim 55).
The ‘341 publication teaches inhalation composition (abstract, [0014]) with delivery to lung tissue [0029] in the form of particles ([0036], [0039]). Organic acids are taught to include citric acid and lactic acid [0192]. It is noted that bolus dose is not defined by the instant specification or claims, therefore the inclusion of lactic acid is deemed to meet bolus dose.
It would have been obvious to one of ordinary skill in the art to substitute a first acid, citric acid, as taught by the ‘821 publication with a second acid, lactic acid, as taught by the ‘341 publication with a reasonable expectation of success because the simple substitution of one known element for another would have yielded predictable results to one of ordinary skill in the art at the time of the invention. M.P.E.P. §2144.07 states "The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).” When substituting equivalents known in the prior art for the same purpose, an express suggestion to substitute one equivalent component or process for another is not necessary to render such substitution obvious. In re Fout, 675 F.2d 297, 213 USPQ 532 (CCPA 1982). M.P.E.P. §2144.06.
Claim(s) 73 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2004/0105821 and Takeuchi as applied to claims 1-2, 4-5, 16, 18-19, 22, 24, 36, 41, 48-50, 56, 58, 61, 65, 75 and 81 above, and further in view of WO 00/61178.
As mentioned in the above 103 rejection, all of the limitations of claims 1-2, 4-5, 16, 18-19, 22, 24, 36, 41, 48-50, 56, 58, 61, 65, 75 and 81 are taught by the combination of the ‘821 publication and Takeuchi.
The ‘178 publication is directed to pulmonary administration of dry powder formulation (title, abstract). Dry powders is taught to be finely dispersed solid particles. Dry powders contain from about 0.1 to 10% moisture, typically contains less than 10 percent moisture. The dry particles are taught as delivered to the lung (page 8, 4th paragraph).
It would have been prima facie obvious to one of ordinary skill in the art to optimize the moisture content in the dry powders taught by the ‘821 publication as the ‘178 publication the moisture content of dry powders delivered to the lungs and the ‘821 publication teaches dry powder delivered to the lungs. One of ordinary skill in the art before the filing date of the claimed invention would be motivated to optimize the moisture content as the ‘178 publication teaches known concentrations of moisture in dry powders delivered to the lungs with a desirable less than 3% moisture and wherein the ’821 publication teaches dry powder, thus it would have been prima facie obvious to one of ordinary skill in the art to use known moisture contents for dry particle compositions to be delivered to the lungs. As MPEP 2144.05 recites “where 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 optimization”.
Conclusion
No claims are allowed.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNDSEY MARIE BECKHARDT whose telephone number is (571)270-7676. The examiner can normally be reached Monday-Thursday 9am to 4pm and Friday 9am to 2pm.
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/LYNDSEY M BECKHARDT/ Examiner, Art Unit 1613
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