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 .
DETAILED ACTION
Claims 11-20 are currently pending in a Response of 01/28/2026.
Please note that current claim 11 has improper status “Currently Amended”, but claim 11 is not amended.
Withdrawn rejections:
Applicant's amendments and arguments filed 01/28/2026 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Any rejection and/or objection not specifically addressed below are herein withdrawn.
The following rejection and/or objection are either reiterated or newly applied. They constitute the complete set of rejection and/or objection presently being applied to the instant application.
Maintained Rejection
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
As indicated above, the present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 11-20 remain rejected under 35 U.S.C. 103 as being unpatentable over Arora et al., “Highly respirable dry powder inhalable formulation of voriconazole with enhanced pulmonary bioavailability’, Expert opinion on drug delivery, 2016, pp. 183-193 (IDS of 06/09/2023) in view of Rabinow et al. (WO2004/096180A1).
Applicant claims the below claim 11 filed on 01/28/2026:
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Level of Ordinary Skill in the Art
(MPEP 2141.03)
MPEP 2141.03 (I) states: “The “hypothetical ‘person having ordinary skill in the art’ to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art.” Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988). The level of skill is that of a medical/pharmaceutical dry powder research scientist, as is the case here, then one can assume comfortably that such an educated artisan will draw conventional ideas from medicine, pharmacy, physiology and chemistry— without being told to do so.
In addition, the prior art itself reflects an appropriate level (MPEP 2141.03(II)).
Determination of the scope and content of the prior art (MPEP 2141.01); Ascertainment of the difference between the prior art and the claims (MPEP 2141.02) and Finding of prima facie obviousness Rational and Motivation (MPEP 2142-2143)
Arora teaches dry powder inhalation formulation comprising 80% voriconazole (VRZ) which overlaps the instant range of 50-85% and 20% leucine which overlaps the instant rage of more than 10%(abstract) and the formulation is present in crystalline form (abstract and Fig. 1) wherein the VRZ is in crystalline form (Fig. 1) and the leucine is also in crystalline form (page 188, right column, line 12); particle size distribution of dried powder having fine particle fraction (FPF) (<5 microns) of 60.26±2.03% (see section 2.4 on page 185, left column and Table 2 on page 187 and Table 4 on page 189)) which the prior art FPF overlaps the instant range of greater than 50% and the particle size overlaps the instant range of MMAD of lower than 5 microns. MPEP 2144.05 states that [I]n the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976) (instant claim 11 (in part), claims 12-13, and 18-20); Table 3 and Fig. 3 of prior art show aerodynamic particle size distribution of VRZ and leucine modified VRZ formulation have MMAD 3.79±0.02 that overlaps the instant range of between 3 and 4.5 microns (instant claim 17). Arora teaches Dx90 is about 6.74 in Sample 3, and however, Arora does not expressly at least 90% of size distribution is lower than 6.0 or 5.0.
Arora does not expressly teach Dx90 of instant claims 1 and 16. However, it would be obvious to optimize Dx90 with the claimed smaller Dx90 from the standpoint of the ordinary artisan because smaller particle size distributions would lead to large surface areas, improving properties including solubility, reactivity and mixing, and Arora teaches overlapping FPF and MMAD values, and thus, unless criticality evidence of the claimed range is given, the Dx90 of prior art would be optimized (instant claims 11 and 16 – at least 90% particle size distribution).
However, Arora does not expressly teach surfactant of instant claims 11, 14 and 15. The deficiency is cured by Rabinow.
Rabinow discloses an antimicrobial composition comprising an aqueous suspension of submicron-to micron-sized particles containing active agent such as voriconazole coated with surfactant such as benzalkonium chloride, cetyltrimethylammonium bromide (=cetrimide), sorbitan esters, sodium lauryl sulfate, polysorbate, phospholipid, bile acid and its salt, polyoxyethylene-polyoxypropylene copolymers (poloxamers), or block copolymer of propylene glycol and ethylene glycol, and the surfactant is used in an amount of about 0.01 to 5% which overlaps the instant range of 0.2 to 2%, and the composition makes the antimicrobial agent potent against organisms normally considered to be resistant to the agent; the composition can further contain amino acid such as leucine (pages 8-16 and claims 1, 5-7, 9-15, 19, 22 and 44-46 of prior art); the composition in the form of particles is administered via various routes including parenteral, nasal, pulmonary, and topical (claim 47 of prior art); and the aqueous suspension of submicron to micron-size particles is in the form of powders (page 7, lines 20-21 and claims 49 and 52 of prior art).
From the standpoint of the ordinary artisan, it would have been obvious to modify the teachings of Arora with addition of surfactant of Rabinow in order to enhance the properties of the powder composition.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
From the combined 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 was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the combined references, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant’s arguments have been fully considered, but are not persuasive.
Applicant argues that Arora fails to teach or reasonably suggest to one of skill in the art how the claimed range would be obtained, and the claimed values represent more than the result of mere routine optimization, and instant Examples 2-15 (see Table 2) having the desired characteristics, as well as detailed discussion regarding a process for manufacturing such products and the relevant nature thereof, and Arora provides a statistically significant range of values which at the very lowest end of the lowest range are ~10% higher than the maximum claimed value; and Arora does not expressly teach surfactant while the claimed invention using surfactant ensures the reduction of electrostatic charges detected in formulations lacking surfactant, smoothness of the powder and maintenance of the solid state in a homogenous way without initial crystallization, etc.; and Rabinow does not disclose inhalation use, and leucine is used as a surfactant or pH adjuster rather than excipient.
The Examiner responds that it is well known that smaller particles has higher surface area which leads to faster dissolution, resulting in improved absorption/bioavailability e.g., as evidenced by EP2654730B1, and here, Table 2 of the instant specification shows FPF 54.5~73.4 and MMAD 3.3-4.3microns, and Arora discloses inside ranges of FPF (<5 micron) 60.26±2.03% and MMAD 3.79 microns. Thus, the claimed D90 would be obvious and optimized unless criticality of the claimed range is shown; Rabinow is relied on for disclosing surfactant, not inhale use and leucine, and even Rabinow discloses the powder composition is applied via nasal route; and the claimed invention does not require inhale use; and when combined with surfactant of Rabinow, it would reveal alleged properties as applicant argued. Lastly, please see case law stating that [O]ne cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. In reKeller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In reMerck & Co., Inc., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). MPEP 2145.
In light of the foregoing, applicant’s arguments are not persuasive.
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 11-20 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-35 of copending application No. 18/265463.
Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets require voriconazole active agent, leucine and surfactant and their identical and/or overlapping amounts. These copending claims differ in scope from the instant claims by virtue of their recitation of the preparation method when compared to the instant composition claims. However, as indicated above, both claim sets require the same ingredients. Further preparation method of copending is disclosed in the instant specification and the same powder composition is also disclosed in the copending ‘463. Consequently, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the copending subject matter.
This is a provisional double patenting rejection since the conflicting claims have not yet been patented.
Response to Arguments
For the reasons set forth above, this double patenting rejection has maintained as Applicants have deferred to rebut the rejection under Provisional Rejection, Obviousness Type Double Patenting.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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 KYUNG S CHANG whose telephone number is (571)270-1392. The examiner can normally be reached M-F 8-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Yong (Brian-Yong) S Kwon can be reached at 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KYUNG S CHANG/Primary Examiner, Art Unit 1613
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