DETAILED ACTION
Previous Rejections
Applicants' arguments, filed 10 August 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 Rejections - 35 USC § 112 – New Matter
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.
Claim 17 is rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement. This is a “new matter” rejection. The claim 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 17 has been amended to recite that the method treats diseases and disorders “characterized by aberrant mTOR pathway activity.” There is insufficient support for this limitation in the originally filed disclosure. The only disclosure of such aberrant mTOR pathway activity is in paragraph [[217] of the instant specification. But this disclosure discusses the use of a particular rapamycin formulation. And in contrast, the claimed composition does not include rapamycin, and thus is different in scope.
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.
Claims 1-8 and 10-14 are rejected under 35 U.S.C. 103 as being unpatentable over Wang (US Patent Application Publication 2008/0175887).
Wang discloses methods of treating respiratory disorders such as asthma by administering, preferably pulmonarily, anti-inflammatory or anti-proliferative drugs (abstract). The drug can be everolimus (paragraph [78]). The drug can be administered as a dry powder (paragraph [49]), and such powders containing the drug and an additive are microparticles sized between 1 and 2 microns (paragraph [61]). Wang further teaches a diluent is present, which can be lactose or mannitol (paragraph [66]), which reads upon the carrier instantly recited.
Thus, Wang discloses compositions comprising the individual elements of the instantly recited composition (carrier, sirolimus or everolimus, and the form of an inhalable dry powder) and together these would provide a composition as instantly recited. However, Wang is not anticipatory insofar as these combinations must be selected from various lists/locations in the reference. It would have been prima facie obvious, however, to make the combination since each component is taught as being useful in making the compositions of the prior art. Since this modification of the prior art represents nothing more than the predictable use of prior art elements according to their established functions a prima facie case of obviousness exists. See MPEP 2141.
Instant claim 2 recites a limitation to the amount of the drug in the powder. And Wang discloses drug is present in from 1 to 99 wt% (paragraph [149]), a range which overlaps the instantly recited range. And in cases involving overlapping ranges, where the instantly claimed ranges “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists. See MPEP 2144.05(A).
Instant claim 3 further limits the size of the drug particles, and the drug-containing powder particles are sized between 1 and 2 microns (paragraph [61]), a range which reads upon or overlaps each of the ranges instantly recited.
Instant claims 4 and 6 recite limitations to the carrier. Wang teaches a diluent is present, which can be lactose or mannitol (paragraph [66]), which are each an option instantly recited. Instant claim 7 recites that two such carriers are used, and each of both lactose and mannitol are suggested, and the use of the combination of the two would have been prima facie obvious. Generally, it is prima facie obvious to combine two compositions, each of which is taught by the prior art to be useful for same purpose, in order to form a third composition to be used for the very same purpose. The idea for combining them flows logically from their having been individually taught in the prior art. See MPEP 2144.06.
Instant claims 5, 7, and 8 recite that one of the two carries is sized from 30 to 100 microns and the other is less than 10 microns, and can both be lactose. The above cited section of Wang suggests 1-2 microns for particles which are delivered to the deep lung (paragraph [61]). And additional sizes taught with respect to inhalation delivery useful include greater than 5 microns (for oral absorption) and about 2 to about 5 microns (upper pulmonary region) (paragraph [54]), and these ranges overlap the instantly recited range.
Claim 10 recites the further inclusion of a surfactant additive. Wang teaches that suitable additives can be surfactants, including those within the scope of this claim (paragraph [93]).
Instant claim 11 recites that the composition “consists essentially of” the microparticles of drug and the particles of the carrier. The instant specification does not provide a clear indication what the basic and novel characteristics actually are for the claimed invention, and as such the transitional phrase “consisting essentially of” will be construed as equivalent in meaning to the term "comprising.” See MPEP 2111.03(III) & PPG v. Guardian, 156 F.3d 1351, 1354 (Fed. Cir. 1998). Dependent instant claims 12-14 recite compositions with the above discussed limitations.
Claim 9 is (and the above cited claims 1-8 and 10-14 are) rejected under 35 U.S.C. 103 as being unpatentable over Wang (US Patent Application Publication 2008/0175887) as applied to claim 1 above, and further in view of Li et al. (US Patent Application Publication 2023/0100760).
Instant claim 9 limits the isomeric B:C ratio of the everolimus, temsirolimus, ridaforolimus, umirolimus, and/or zotarolimus. There is no support for this limitation in the instant specification, as isomers and ratios thereof are only discussed for rapamycin (see paragraph [74]). There also is no support for isomers of these drugs in any of the parent patent applications as well. Thus, the effective filing date of instant claim 9 is considered 23 April 2024, the actual filing date of the instant application.
Wang teaches most of the limitations recited by instant claim 9, except for the isomer of everolimus used. This drug generally is suggested, but no discussion of the specific isomeric forms is provided.
Li et al. remedies this deficiency, as Li et al. discusses purified forms of everolimus (paragraph [28]), which comprise less than 0.1% of the undesirable isomers A and C and are primarily isomer B (id.).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time of filing to have used the everolimus as disclosed by Shaw et al., being primarily the B isomer, in the composition taught by Wang. Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07.
Response to Arguments
The Applicant argues that the obviousness rejection is not proper. The Applicant argues that the claims are structurally distinct and differ fundamentally from what Wang discloses. The claims describe an interactive mixture in which drug microparticles are associated with separate carrier particles. The drug adheres to the surfaces of the larger carrier particles. In contrast, Wang, discloses that the particles of diluent have embedded drug.
The Examiner acknowledges the arguments presented, but does not consider them persuasive. It is noted that the features upon which Applicant relies (i.e., these specific arrangements) are not recited in the rejected claims. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993) & MPEP 2145.
The Applicant also argues that there would not have been a reasonable expectation of success to select the specific rapamycin derivative from the extensive genus disclosed by Wang. The selection of these options requires impermissible hindsight. The Examiner is not persuaded by this argument. Wang clearly suggests these ingredients, and how they all can be in the inventive compositions disclosed. Thus, no hindsight is being relied upon, as the reference itself suggests these ingredients.
The Applicant further states that the prior art teaches away from the claimed invention, as supported by the art cited in the instant specification. The Examiner does not agree. Wang clearly suggest inhalation of rapamycin for pulmonarily treatment. Thus, Wang is considered to provide its own reasonable expectation of success, given the references state that inhalation is a useful way to deliver the drug. And the cited reference is not considered to rebut the expectation. This reference cites another reference from 2006 to support the statement regarding safety (paragraph [64]), but the reference citation does not make clear what is being cited (no journal name), and thus it is unclear what the reference is showing.
The Applicant further argues that rapamycin was known to cause serious and potentially life threatening lung toxicity, and unexpectantly the Applicant has found that rapamycin can be delivered directly to the lung without toxicity.
The Examiner acknowledges the evidence and arguments presented, but does not consider them persuasive. Wang (cited above in the rejections) discusses using rapamycin pulmonarily and delivering it via inhalation. Both references clearly suggest inhalation of rapamycin for pulmonarily treatment. Thus, this reference is considered to provide their own reasonable expectation of success, given the references state that inhalation is a useful way to deliver the drug.
Furthermore, in response to the arguments regarding what would have been expected at the time of filing and with respect to the arguments of unexpected effects, the Examiner cites PCT Patent Application Publication WO 2015/054280, which is not being relied upon for the rejection but instead is being cited to respond to Applicant’s arguments. This reference demonstrates that before the filing date of the instant invention it was known and expected that rapamycin could be delivered via aerosol inhalation (abstract) such that administration results in low pulmonary toxicity and with the probability of no or substantially fewer adverse events due to systematic exposure of the rapamycin (paragraph [16]). Thus, the low toxicity does not appear to be unexpected, and thus not found persuasive for overcoming the rejection.
The Applicant also argues (with respect top instant claim 11) that the specification does identify the basic and novel characteristics of the invention (ability to deliver rapamycin derivatives with therapeutic efficacy while avoiding lung toxicity). And materials that affect this would be excluded. The Examiner does not find this argument persuasive. Even if en arguendo the Applicant has identified the basic and novel features, there is no basis to support that the ingredients present in Wang would impact this feature. Thus, they are not considered excluded.
The Applicant also argues that the obviousness rejection of instant claim 9 is not proper. The Applicant states that Li et al. is not analogous art, as Li et al. is directed to formulations applied to the skin whereas the claimed invention is directed to inhalable powders. Further, the stability is for solutions, not solid state, and thus there would noty be a reasonable expectation of success for this combination.
The Examiner does not consider these references non-analogous. Both are directed to pharmaceutical formulations of rapamycin derivatives. And this material would have been obvious to include in the composition disclosed by Wang. Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07.
Allowable Subject Matter
Claims 15 and 16 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter. With respect to claims 15 and 16, the closest prior art is considered to be above cited Wang (US Patent Application Publication 2008/0175887). Wang discloses methods of treating respiratory disorders by administering, preferably pulmonarily, rapamycin (abstract). The drug can be administered as a dry powder and the powders contain the drug and an additive. However, the instantly claimed invention excludes anything other than the drug (rapamycin) and carrier particles, with additives and surfactants both excluded from the composition.
Conclusion
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 Brian Gulledge whose telephone number is (571) 270-5756. The examiner can normally be reached Monday - Friday 7am - 4pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fereydoun Sajjadi can be reached at (571) 272-3311. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Brian Gulledge/Primary Examiner, Art Unit 1699
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