Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 2/6/2026 has been entered.
Status of Claims
Claims 1, 4-8, and 12-16 are pending. Claims 6 and 15-16 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
An action on the merits of claims 1, 4, 5, 7, 8, and 12-14 is contained herein.
Previous Objections/Rejections
Any rejections or objections stated of record in the office action mailed on 11/6/2025 that are not explicitly addressed herein below, are hereby withdrawn in light of applicant's arguments and/or amendments filed 2/6/2026.
New Rejections
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived 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(a) 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 under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
Claims 1, 4, 5, 7, 8, and 12-14 are rejected under 35 U.S.C. 103(a) as being unpatentable over US 20070243216 (‘216), US 20060040953 (‘953), US 20100086609 (‘609) and further in view of US 20040241232 (‘232) and US Pat. No. 6989155 (‘155).
‘216 teaches a pharmaceutical composition comprising prostaglandins (claim 1) (see abstract, [0001]; and ref. claim 4 of ‘216) such as (PG-E1) which is useful for treating asthmas which is considered to a local lung disease (see [0005], ‘216) wherein said PG-E1 is an analog of “PG-12”) which is used in the treatment of lung disease; and wherein the prostaglandin compound can be formulated in a powder form which is administered via inhalation ([0005], lines 13-15, ‘216) wherein the prostaglandin composition is a pharmaceutical composition (see [0001], ‘216). Said pharmaceutical composition also comprises “stabilizer” ([0001], ‘216). Since the stabilizer can be “diketopiperazine” (DKP) (see the corresponding discussion of ‘609 below) wherein DKP is considered to be a drug “carrier” (as evidenced by [0076], instant specification), claim 5 is rejected. In addition, ‘216 has suggested a single dose (see [0011], ‘216) which is an obvious variation of “an inhalable unit dose” or containers [0026] such as “cartridge” (claim 4).
Since “…is for treating moderate to severe pain” (claim 7) is considered to be an “intended use” which carries no patentable weight for the claimed product; and thus, claim 7 is rejected.
Provided that ‘216 does not expressly teach formulation the prostaglandin with DKP or FDKP.
The drug delivery prior art (‘609) teaches that DKP serves both to stabilize and enhance delivery of the entrapped material (drugs) (see [0024], lines 1-6, ‘609) wherein DKP is prepared in form of microparticles ([0087], lines 1-2, ‘609) wherein DKP compounds provide sufficient stabilization of unstable or labile drugs (see [0091], ‘609). Also, ‘609 disclose the species of “DKP” that is “fumaryl diketopiperazine” for delivery of drug to lung by pulmonary route (see [0025], ‘609), i.e., inhalation delivery; wherein said “fumaryl diketopiperazine” is alternative name of “3, 6-di(4-X-aminobutyl)-2.5-diketopiperazine wherein X is fumaryl” (evidenced by ref. claim of ‘609). The formulation comprising dry powder form of FDKP for inhalation (ref. claim 2 of ‘609). The teachings of ‘609 thus provides solution for the problem “unstable” and “instability” of the drug prostaglandins (see the following discussion for detail).
The prostaglandin of ‘216 is formulated with the “stabilizer” (see [0001], ‘216); this is due to the fact that the prostaglandins are difficult to formulate in storage-stable solutions, as they tend to be hydrolytically unstable ([0015], lines 1-2, ‘216), i.e., instability, and both PG-E1 and PG-12 are chemically unstable, they are poor in retaining pharmacological effects (see [0019], lines 10-12, ‘216).
It is noted that the “disodium salt” (claim 14) of FDKP is a design choice and it has been known in the FDKP-drug delivery prior art (‘953) that the dried microparticles of FDKP disodium salt (claim 14) formulated with a drug have increased stability for said drug (see [0024]-[0028] and [0074], ‘953). Thus, claim 14 is rejected.
Thus, it would have been obvious to one of ordinary skill in the art at the time the invention was made to formulate drug prostaglandin (claim 1) in order to overcome the drawback the “instability” (due to the “hydrolytically unstable”, see above discussion) of said prostaglandin drug thereby to improves the delivery thereof [advantage], wherein FDKP (a diketopiperazine) DKP serves both to stabilize and enhance delivery of the entrapped material (drugs) ([0024], lines 1-6, ‘609) and wherein peptide drug trapped in fumaryl diketopiperazine (FDKP) markedly improve [advantage] its stability as dry powder form (see [0123], lines 4-6, ‘609). Also, it has been known in the art (‘216) that prostaglandin such as PG-I2 which been known to have broad range of pharmaceutical activities ([0019], lines 4-6, ‘216), i.e., usefulness in medical application. Have been motivated by said “advantages”, one of ordinary skill in the art would have readily formulated the prostaglandin drug with FDKP microparticles in the dry powder formulation for inhalation delivery of said drug, and would have administered to a patient (subject) who is suffering from a lung disorder such as asthma (‘216) the dry powder formulation in order to treat the lung disorder (such as asthma) with reasonable expectation of success. Therefore, the combination of references’ teachings renders claims 1-5, 7, 8, 13, and 14 prima facie obvious.
Provided that ‘216, ‘609, and ‘953 does not expressly teach that the dry powder composition further comprises an aliphatic amino acid such as leucine.
‘232 teaches that a pharmaceutical composition comprising “respirable sized excipient fraction” that preferably comprises diketopiperazine (DKP) and amino acid “leucine” (see [0075], lines 6-8 and 9; and [0073], lines 1-4, ‘232). Said “respirable sized excipient fraction” enhances the bioactivity of the pharmaceutical composition ([0073], lines 1-4, ‘232) wherein the fraction contains respirable sized excipient particles suitable for pulmonary (inhalation) delivery ([0074], lines 1-3, ‘232).
The inhalation prior art (‘155) teaches a powder composition for inhalation, and teaches that amino acid is particularly advantageous for use in a powder for inhalation wherein amino acids are bio-compatible and relatively safe for inhalation wherein the amino acid is advantageously “leucine” that is aliphatic amino acid (see col.4, lines 24-25, 29-37 and 42-43, ‘155) which is the common subject matter of ‘232 (see above). It has been found that the amount of up to 10% by weight of the amino acids of powder advantageously improves the dispersal of the active particle and improves powder performance (see col.4, lines 49-55, ‘155) which is the common subject matter of ‘609 (see [0013], [0093]; and [0123], lines 4-6, ‘609). The addition of low-density amino acid (such as leucine) to a powder inhalation composition has been known to provide an improved respirable fraction [advantage] for the powder inhalation (col.4, lines 44-48, ‘155).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to add the amino acid such as leucine into the dry powder formulation comprising DKP/FDKP and prostaglandins (‘216). This is because the prior art has disclosed feasible formulation of the amino acid “leucine” with DKP suitable for pulmonary delivery (‘232) wherein FDKP (‘609) is a species of DKP compound, and because relative art (‘155) has taught that amino acid is particularly advantageous for the powder inhalation wherein amino acids are bio-compatible and relatively safe for inhalation, and has taught the appropriate amount of said amino acid of up to 10% by weight which provides the improvement of inhalable (respirable) power when administered (see above discussion).
It has been known that prostaglandins are useful for treating disorders such as myocardial ischemia, post-operative thrombosis, arteriosclerosis, and blood clotting defects due to lipemia (see [0007], ‘216). Thus, one of ordinary skill in the art would have readily formulated the drug “prostaglandins” with amount of the amino acid and FDKP suitable to form a desired inhalation power for better treating the above mentioned disorders with reasonable expectation of success.
Therefore, the combination of the references’ teachings renders the claims prima facie obvious.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN E MCDOWELL whose telephone number is (571)270-5755. The examiner can normally be reached on 8:30-6 MF.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Murray can be reached at 571-272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN E MCDOWELL/ Primary Examiner, Art Unit 1624