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 .
Formal Matters
Receipt of Applicant’s response dated 08/05/2026 is acknowledged.
Claims 1-20 are pending.
Election/Restriction
Applicant has elected the following species without traverse in the reply dated 08/05/2026:
Leucine as the species of aliphatic amino acid further included in the dry powder composition;
Sumatriptan as the species of the triptan further comprised in the dry powder composition; and
Rapid acting insulin as the species of what the dry powder composition is used in combination therapy with.
Claims 1-20 are under consideration in the instant Office action to the extent of the elected species, i.e., the aliphatic amino acid further included in the dry powder composition is leucine, the triptan further comprised in the dry powder composition is sumatriptan, and the dry powder composition is used in combination therapy with a rapid acting insulin.
Information Disclosure Statement
The information disclosure statement (IDS) filed 06/30/2026 has been considered by the Examiner. A signed copy of the IDS is included with the present Office Action.
Specification
The abstract of the disclosure is objected to because it is too short and, thus, does not properly convey to the reader the subject matter of the invention. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length. See MPEP § 608.01(b).
A corrected abstract of the disclosure is required.
The disclosure is objected to because of the typographical errors of “Willi” appearing as “Willie” in line 2 of Par. [0075] of the specification and line 2 of Par. [0076] of the specification.
Applicant’s cooperation is requested in checking the rest of the disclosure for informality errors and making changes accordingly.
Appropriate correction is required.
Claim Objections
Claims 1 and 19 are objected to because of the following:
In line 3 of claim 1, “form a compound” should be amended to “form of a compound” for grammatical correctness (See claim 19); and
In line 3 of claim 19, “inhaler a” should be amended to “inhaler comprising a” for grammatical correctness.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 8-9, 12, and 17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
(a) Each of claims 8 and 12 are indefinite because, in each claim, it is not specified what each recited percent by weight is with respect to. Is each percent by weight relative to the total weight of the dry powder composition or relative to something else? As written, one skilled in the art would not be reasonably apprised of the metes and bounds of the claims.
(b) Each of claims 8 and 9 recite the limitation "the aliphatic amino acid" in line 1. There is insufficient antecedent basis for this limitation in each of claims 8 and 9 because neither claims 8 or 9, or claims 7 or 1, earlier recite “an aliphatic amino acid”.
(c) Claim 17 is indefinite in the recitation “10 mg by weight” because it is unclear what is meant by a mass by weight. Does the recitation intend to mean “10 mg”, “10% by weight relative to the total weight of the dry powder composition”, or something else? As written, one skilled in the art would not be reasonably apprised of the metes and bounds of the claims.
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.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Leone-Bay et al (US 8,785,396 B2, published 07/22/2014, cited in IDS dated 06/30/2026) in view of Yang et al (Orphanet. J. Rare Dis., 2017, 12, 146, published 08/30/2017, cited in IDS dated 06/30/2026).
Leone-Bay et al teach methods for the treatment of disease, including, endocrine disease, such as diabetes, hyperglycemia and obesity comprising administering to a patient in need of treatment a formulation (See entire document, e.g., Col. 11 Lines 3-5, 19-21). An active agent, such as glucagon-like peptide 1 (GLP-1), is formulated into a dry powder composition comprising a diketopiperazine, such as 3,6-di(fumaryl-4-aminobutyl)-2,5-diketopiperazine (fumaryl diketopiperazine, FDKP), which can be crystalline or amorphous, and is delivered into the systemic circulation by pulmonary inhalation using a cartridge and a dry powder inhaler (e.g., Col. 8 Line 60, Col. 10 Lines 27-28, Col. 12 Lines 1-9). Leone-Bay et al teach administering the dry powder composition to the patient by inhalation using a breath powered, dry powder inhaler with or without a container, wherein the container can be a cartridge, such as a unit dosing cartridge for a reusable inhaler, or a single use inhaler (e.g., Col. 4 Lines 34-40).
Leone-Bay et al teach that the formulation may be used in a method directed to the treatment of diabetes, hyperglycemia and/or obesity, wherein formulations comprising GLP-1 may be used in combination with one or more other active agents (e.g., Col. 12 Lines 39-42). Leone-Bay et al teach examples containing a dosing of active agents totaling 1.5, 2, or 3 mg (e.g., Examples). Leone-Bay et al teach that the formulation comprising GLP-1 may be administered immediately before a meal (preprandially), at mealtime (prandially), and/or at about 15, 30 or 45 minutes after a meal (postprandially) (e.g., Col. 14 Lines 11-14).
Leone-Bay et al teach that when the method is used to treat hyperglycemia and/or diabetes, for example Type-2 diabetes mellitus, GLP-1 can be administered with insulin as a combination therapy and given prandially. In this case, GLP-1 and insulin can be co-formulated in a dry powder formulation for inhalation using a diketopiperazine (e.g., Col. 16 Lines 56-66). The inhalable GLP-1 and insulin combination therapy can comprise a rapid acting insulin (e.g., Col. 17 Lines 30-32). Leone-Bay et al teach that when the method is used to treat obesity, GLP-1 can be administered as an inhalable dry powder formulation comprising a diketopiperazine and may be administered in combination with one or more endocrine hormone and/or anti-obesity active agents for the treatment of obesity, for example pramlintide acetate (e.g., Col. 18 Lines 22-33).
The formulation can further comprise a vasoconstrictor as active agent, for example serotonin receptor agonists including, triptans such as sumatriptan, in amounts ranging from at least about 0.1 mg to about 50 mg or less (e.g., Col. 19 Lines 47-54, 57-61). The formulation can further comprise an aliphatic amino acid, for example leucine or L-leucine, from about 0.5% to about 30% by weight of the composition (e.g., Col. 20 Lines 5-11). The pharmaceutical composition may comprise a dry powder for oral inhalation comprising FDKP disodium salt, sumatriptan and L-leucine (e.g., Col. 20 Lines 11-14).
Leone-Bay et al do not teach Prader-Willi syndrome as one of the diseases that can be treated.
This deficiency is made up for in the teaching of Yang et al.
Yang et al teach that Prader-Willi syndrome in patients leads to obesity and often develops into Type-2 diabetes mellitus (See entire document, e.g., Par. 2 of Background on Page 1).
It would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to treat obesity and/or Type-2 diabetes mellitus in a patient suffering from Prader-Willi syndrome using the method of Leone-Bay et al discussed supra. One of ordinary skill in the art would have been motivated to do so and there would have been a reasonable expectation of success because the method of Leone-Bay et al is taught for the treatment of diseases including obesity and Type-2 diabetes mellitus and Yang et al teach that patients suffering from Prader-Willi syndrome often develop obesity and/or Type-2 diabetes mellitus.
Regarding the ranges required by the instant claims, a prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art (In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003)).
Thus, the modified method of Leone-Bay et al in view of Yang et al renders obvious instant claims 1-20 to the extent of the elected species.
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 conflicting claims 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) 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 www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 12,370,137 B2 (hereafter ‘137) in view of Leone-Bay et al (US 8,785,396 B2, published 07/22/2014, cited in IDS dated 06/30/2026).
Although the claims at issue are not identical, they are not patentably distinct from each other because:
Instant claims 1-20 recite a method of treating Prader-Willi syndrome in a subject, the method comprising: administering via inhalation a dry powder composition including pramlintide and a crystalline, amorphous, or crystalline composite form a compound having a formula:
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, wherein the administering is in a single inhalation, wherein the administering is immediately prior to beginning a meal, the administering is prandially, wherein the administering is at time 0, wherein the subject is obese, wherein the dry powder composition further includes alanine, glycine, leucine, isoleucine, norleucine, serine or a combination thereof, wherein the aliphatic amino acid is about 0.5% to about 30% by weight, wherein the aliphatic amino acid is L-leucine, wherein the dry powder composition further comprises insulin, wherein the insulin is a rapid acting insulin, wherein the insulin comprises up to about 30% by weight, wherein the dry powder composition further comprises a serotonin receptor agonist, wherein the serotonin receptor agonist is a triptan, wherein the triptan is sumatriptan, zolmitriptan, rizatriptan, naratriptan, almotriptan, eletriptan, or frovatriptan, wherein the dry powder composition is used in combination therapy with a rapid acting insulin, fluoxetidine, or duloxetine, or combinations thereof, wherein the pramlintide is present up to 10 mg by weight, wherein the pramlintide is present up to 3 mg of dry powder composition for a single dose, and a method of treating Prader-Willi syndrome, the method comprising: providing to a subject a unit dose cartridge configured to be used in a dry powder inhaler a dry powder composition including pramlintide and a crystalline, amorphous, or crystalline composite form of a compound having a formula:
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, wherein the dry powder inhaler is reusable.
Claims 1-12 of ‘137 recite an inhalable dry powder pharmaceutical composition comprising a crystalline, amorphous, or crystalline composite form of fumaryl diketopiperazine having the formula:
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leucine; and pramlintide, wherein said inhalable dry powder pharmaceutical composition in the form of microparticles, and about 35% to about 75% of the microparticles have an aerodynamic diameter of less than 5.8 μm, wherein the composition is effective in the treatment of obesity associated with Prader Willi Syndrome, wherein the leucine is about 0.5% to about 30% by weight of the composition, wherein the composition is used in combination therapy with a rapid acting insulin, fluoxetidine, duloxetine, or combinations thereof, wherein the pramlintide is present up to 10 mg (wt %) of the pharmaceutical composition, wherein the pramlintide is present up to 3 mg of dry powder for a single dose, and wherein the leucine is L-leucine, an inhalable dry powder pharmaceutical composition comprising a crystalline, amorphous, or crystalline composite form of fumaryl diketopiperazine having the formula:
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an aliphatic amino acid selected from the group consisting of: alanine, glycine, leucine, isoleucine, norleucine and serine; optionally a pharmaceutically acceptable excipient; and two active agents, said active agents are present consisting of pramlintide and insulin, wherein the insulin is present and comprises up to about 30% (wt %) of the pharmaceutical composition, wherein said inhalable dry powder pharmaceutical composition comprises microparticles, and about 35% to about 75% of the microparticles have an aerodynamic diameter of less than 5.8 μm, and wherein the composition is effective in the treatment of obesity associated with Prader Willi Syndrome, an inhalable dry powder pharmaceutical composition for comprising a crystalline, amorphous, or crystalline composite form of fumaryl diketopiperazine having the formula:
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an aliphatic amino acid selected from the group consisting of: alanine, glycine, leucine, isoleucine, norleucine and serine; optionally a pharmaceutically acceptable excipient; and three active agents, said active agents are present consisting of a serotonin receptor agonist, pramlintide, and insulin, wherein the insulin comprises up to about 30% (wt %) of the pharmaceutical composition, wherein said inhalable dry powder pharmaceutical composition comprises microparticles, and about 35% to about 75% of the microparticles have an aerodynamic diameter of less than 5.8 μm, and wherein the composition is effective in the treatment of obesity associated with Prader Willi Syndrome, wherein the insulin is a rapid acting insulin, wherein the serotonin receptor agonist is a triptan, wherein the triptan is sumatriptan, zolmitriptan, rizatriptan, naratriptan, almotriptan, eletriptan, or frovatriptan, and inhalable dry powder pharmaceutical composition comprising a crystalline, amorphous, or crystalline composite form of fumaryl diketopiperazine having the formula:
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an aliphatic amino acid selected from the group consisting of: alanine, glycine, leucine, isoleucine norleucine and serine; optionally, a pharmaceutically acceptable excipient; and an active agent, said active agent is present consisting of pramlintide, effective in the treatment of obesity associated with Prader Willi Syndrome, wherein said inhalable dry powder pharmaceutical composition comprises microparticles, and about 35% to about 75% of the microparticles have an aerodynamic diameter of less than 5.8 μm.
Claims 1-12 of ‘137 do not recite the treatment including administering the composition to the subject in a single inhalation, the administering being immediately prior to beginning a meal, the administering being prandially, the administering being at time 0, or the administering involving providing to the subject a unit dose cartridge configured to be used in a dry powder inhaler comprising the composition, wherein the dry powder inhaler is reusable.
These deficiencies are made up for in the teaching of Leone-Bay et al, which has been discussed in detail supra.
It would have been prima facie obvious to one of ordinary skill in the art to treat obesity associated with Prader Willi Syndrome in a subject using a method involving administering the composition of claims 1-12 of ‘137 using the method taught by Leone-Bay et al discussed supra. One of ordinary skill in the art would have been motivated to do so and there would have been a reasonable expectation of success because Leone-Bay et al teach a method of treating diseases including obesity using a similar composition as that recited in claims 1-12 of ‘137.
Thus, claims 1-12 of ‘137 in view of Leone-Bay et al render obvious instant claims 1-20 to the extent of the elected species.
Conclusion
No claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAELEIGH ELIZABETH OLSEN whose telephone number is (703)756-1962. The examiner can normally be reached M-F 8-5 PM.
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/K.E.O./Examiner, Art Unit 1619
/NICOLE P BABSON/Primary Examiner, Art Unit 1619
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