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 .
Claims 1-6 are pending and examined on the merits.
Claim Rejections - 35 USC § 102 - Anticipation
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 (i.e., changing from AIA to pre-AIA ) 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 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) 1-6 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Trapnell et al. (Inhaled Molgramostim Therapy in Autoimmune Pulmonary Alveolar Proteinosis [aPAP]. N Engl J Med 2020;383(17):1635-1644. https://www.nejm.org/doi/full/10.1056/NEJMoa1913590 Published September 7, 2020, one month before the instant application priority date. NOTE: The examiner notes this published study was funded by an entity designated as Savara Pharmaceuticals/Savara Inc. (Instant Applicant), but not authored by the sole inventor here (Cecilia Ganslandt)).
Trapnell teach “aPAP [patients] to receive the recombinant GM-CSF molgramostim (300 μg once daily by inhalation), either continuously or intermittently (every other week).” Though not uncovered by KWIC search, it is presumed a stabilizer (e.g. albumin) was equally employed (instant claims 2-3), as all other limitations (instant claims 1, 4-6) of the instantly claimed invention are otherwise taught by Trapnell (a study funded by Applicant Savara Inc., but not authored by the sole instant invention Ganslandt). Claims 1-6 are thus presently deemed anticipated by Trapnell.
Claim Rejections - 35 USC § 103 - Obviousness
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 (i.e., changing from AIA to pre-AIA ) 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, 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.
Claim(s) 1-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dunn et al. (U.S. Patent No. 6,019,965) in view of WO2007009208 (“Cangene” Corpoaration; published 01/25/2007, simply to identify that mogramostim is a known GM-CSF, where Cangene refers to Dunn et al. at page 11, line 8 that GM-CSF’s are used in treating alveolar proteinosis) and EP 3662924 (Reponex Pharmaceuticals A/S, published 06/10/2020, a few months prior to the instant priority date of 10/2/2020; hereafter “Reponex”).
Primary reference Dunn, as to instant claims 1 and 4-6, teach administering an effective amount of any GC-CSF for moderate-severe pulmonary alveolar proteinosis (aPAP) by inhalation via any type of nebulizer/nebuliser (claims 1-2, 4 noting that claim 1 misspelled CSF as SCF; col. 4, lines 45-48; col. 4, lines 36-39). Relevant to instant claims 4-5, Dunn puts not limit that such is not continuous daily administration or intermittently, allowing for any routinely optimizable routine by the attending physician. Dunn also puts no limit on the ‘type’ of nebulizer/nebulizer, allowing for any known type depending on preference. [Note: Dunn at col. 4, lines 32-48 also teach treating lung infections with the same employing nebulizer/nebulizer, as secondary reference Reponex below teaches GC-CSF variant molgramostim may be used for.].
Primary reference Dunn does not expressly teach the known, interchangeable GC-CSF variant and molgramostim (instant claim 1) or the use of a stabilizer of albumin therefore.
Cangen fills both these gaps as to molgramostim and stabilizer albmin, relevant to instant claims 1-3, where Cangen teach the GM-CSF may be molgramostim (page 4, para 2; page 9, para 6) and the condition to be treated may be pulmonary alveolar proteinosis (aPAP) (page 11, line 8, referring to U.S. Patent No. 6,019,965, relevant to the latter, a GM-CSF for treating aPAP, wherein Cangen here recites that molgramostim is an interchangeable GM-CSF variant), further comprising the stabilizer albumin (page 10, para 2). Therefore, it would have been prima facie obvious to employ molgramostim as the GM-CSF in Dunn as well as adding a stabilizer such as albumin therein.
Primary reference Dunn - although teaching pharmaceutically effective amounts for treating aPAP with GM-CSF’s (which Cangen teach the GM-CSF molgamostim) and by inhalation - does not teach administering 300 ug per day.
Reponex fills this gap as to administering 300 ug/day of instant claim 1 and also teaches/suggests instant claims 4-6 by teaching: administration of “at least 300 micrograms of GM-CSF is administered per day” (claim 20), wherein the GM-CSF is.molgramostim (claim 26; para 39-40), for intraalveolar and/or pulmonary alveolar treatment (claim 1 to which claim 20 depends back to; and e.g. para 114 and para 113), using any type of nebulizer (para 99, 110-114, claim 3; see especially para 113 drawn to specialized nebulizers immediately followed by para 114 which states: “Improved penetration of the inhaled composition to its target site, which includes the small airways (bronchioles and alveoli), may be obtained by: (i) Giving a higher dose-rate of the inhaled composition in order to achieve the wanted effect.”); and wherein the treatment regimen may be continuous or continuously intermittent (relevant to instant claims 4-5) “periods of administration” which is “all at the discretion of the attending physican” (para 96, per the broadest reasonably interpretation thereof). Therefore, it would have been prima facie obvious to administer the GC-CSF mogramostim by alveolar nebulizer (of any type) at an effective dose of 300 ug per day in Dunn based on Reponex employing the same for alveolar conditions as taught in Dunn (including alveolar infections).
The instantly claimed invention is presently found prima facie obvious over the combination of references applied above, absent evidence (test data) of secondary considerations of unexpected results employing only 300 ug daily versus other valid controls (e.g. other ug amounts and/or more than once daily).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAURY AUDET whose telephone number is (571)272-0960. The examiner can normally be reached on M-Th. 7AM-5:30PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lianko Garyu can be reached on 571-270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MAURY A AUDET/Primary Examiner, Art Unit 1654