DETAILED CORRESPONDENCE
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 10/17/25 has been entered.
Receipt is acknowledged of Amendments and Remarks filed on 10/17/25. Claims 1 and 10 have been amended, no new claims have been added and no claims have been canceled. Claims 1, 3-5, 7, 10-17 are pending. Claim 15 is withdrawn. Accordingly, claims 1, 3-5, 7, 10-14 and 16-17 are under examination on the merits.
Rejections and/or objections not reiterated from the previous Office Action are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
Claim Rejections - 35 USC § 112
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.
Claim 5 is 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.
Claim 5 recites the limitation "formulation comprises an active ingredient" in the inhalation system of claim 1. There is insufficient antecedent basis for this limitation in the claim. Claim 1 does not support an active ingredient. Claim should contain the term “further” to obviate this rejection.
Claim Objections
Claims 10 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 5. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim 10 and claim 5 (which depends on claim 1) differ in that claim 10 recites the limitation of “a breath-powered dry powder inhaler” while claim 1 recites a dry powder inhaler. However not only the Specification does not support any inhaler other than breath-powered, the features of the inhaler of claim 1 are disclosed as a breath-powered inhaler in the Specification. As such claim 10 containing an active ingredient and all the features of claim 1 is a duplicate of claim 5.
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 1, 3-5, 7, 10-14 and 16-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 9,393,372. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims anticipate the instant claims. The said instant claims are generic to all that is recited in reference claims. That is, the instant claims fall entirely within the scope of the reference claims.
Instant claim 1 is drawn to a multi-dose inhalation system, comprising: a dry powder inhaler; and a cartridge configured to adapt to said dry powder inhaler and reconfigurable in the inhaler from a sealed containment configuration to an open dosing configuration; said cartridge containing a dry powder formulation comprising a plurality of powder particles of a diketopiperazine, and said cartridge configured wherein 20% to 70% of the total airflow through the inhalation system enters and exits the cartridge then converges perpendicularly with the airflow bypassing the cartridge; and further wherein said cartridge comprises a dispensing port narrower in cross-section than said container, such that the velocity of the dry powder is changed as the dry powder exits the container; wherein the inhalation system is configured to deliver the diketopiperazine to the pulmonary circulation of a subject from a single inhalation, and wherein peak inhalation pressure drops of between 2 and 20 KPa produce resultant peak flow rates of about between 7 and 70 liters per minute.
Reference claim 1 is drawn to an inhalation system comprising a dry powder inhaler comprising a mouthpiece and a container, wherein the container comprises a top and a bottom which are movable relative to one another, and wherein 20-70% of the total air flow through the inhaler enters and exits the container, a second flow path for 30-80% of the volume of air through the inhaler, wherein the inhalation system is configured to deliver the diketopiperazine to the pulmonary circulation of a subject, and said diketopiperazine is measured in a subject's plasma having an AUC greater than 2,300 ng*min/mL per mg of diketopiperazine content in the dry powder formulation.
The difference between the recited claims of the instant application and the reference claims is that the instant application claims do not expressly recite the limitations of a first and a second flow path whereas reference claims do. However, the recited claims of the instant application are not mutually exclusive since the inhaler of the instant application is the same as that claimed by reference claims. In other words, all the limitations of the instant claims are within the scope of reference claims.
Claims 1, 3-5, 7, 10-14 and 16-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 8,485,180. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims anticipate the instant claims.
Instant claim 1 is delineated above.
Claim 1 of the ‘180 Patent recites an inhalation system, comprising: a dry powder formulation comprising a plurality of powder particles of a diketopiperazine; and a dry powder inhaler configured to deliver the powder particles to the pulmonary circulation of a subject in a single inhalation and having a container including a cup-like chamber with two relatively flat and parallel sides and a relatively rounded bottom having an internal volume containing the powder particles and a mouthpiece; portions of the inhaler defining a first flow path for 20-70% of the volume of air through the inhaler, said first flow path leading from an inlet to the chamber through the chamber and through at least one outlet from the chamber to the mouthpiece, the inlet and the at least one outlet being configured so that an air flow entering the chamber re-circulates within the internal volume of the chamber tumbling the particles and entraining them in the air flow; the inlet and the at least one outlet further being configured so that the air flow from the inlet is directed across the at least one outlet and controls exit from the chamber of powder particles entrained within the air flow; portions of the inhaler defining a second flow path for 30-80% of the volume of air through the inhaler, said second flow path by-passing the inlet into the chamber and merging with the first path as the first path leaves the at least one outlet; the first flow path changing in direction where it merges with the second flow path, fluidized powder particles exiting the at least one outlet being sheared on contact with the air flow in the second flow path; wherein the inhalation system is configured to deliver the diketopiperazine to the pulmonary circulation of a subject, and said diketopiperazine is measured in a subject's plasma having an AUC greater than 2,300 ng*min/mL per mg of diketopiperazine content in the dry powder formulation.
The difference between the recited claims of the instant application and the reference claims is that the instant application claims do not expressly recite the limitations of the inhaler or a second flow path whereas reference claims do. However, the recited claims of the instant application are not mutually exclusive since the inhaler of the instant application is the same as that claimed by reference claims. In other words, all the limitations of the instant claims are within the scope of reference claims.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 and 11 of U.S. Patent No. 8,636,001. Although the claims at issue are not identical, they are not patentably distinct from each other because the examined claims would have been obvious over the reference claims.
Instant claim 1 is delineated above.
Reference claims 1 and 11 recite an inhalation system for delivering a dry powder medicament to a pulmonary tract, comprising a dry powder inhaler configured to have at least two inlet apertures, wherein a first inlet aperture is in communication with a first air flow pathway and a second inlet aperture is in communication with a second air flow pathway, and a container to enclose the dry powder medicament wherein the dry powder medicament comprises diketopiperazine particles. Claim 5 is directed to the inhalation system of claim 3, wherein the cartridge comprises a cartridge top and a cartridge bottom, wherein the cartridge top and the container are configurable to attain a containment position and a dosing or dispensing position.
The difference between the recited claims of the instant application and the reference claims is that the instant application claims do not expressly recite the limitations of the inhaler or a second flow path whereas reference claims do. However, the recited claims of the instant application are not mutually exclusive since the inhaler of the instant application is the same as that claimed by reference claims. In other words, all the limitations of the instant claims are within the scope of reference claims.
Claims 1, 3-5, 7, 10-14 and 16-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8 and 13-18 of U.S. Patent No. 8,424,518 in view of Steiner et al (6,071,497). Although the claims at issue are not identical, they are not patentably distinct from each other because the examined claims would have been obvious over the reference claims in view of Steiner et al and Leon-Bay et al.
Instant claim 1 is delineated above.
The reference claims are drawn to a dry powder medicament cartridge for an inhaler, comprising: an enclosure configured to hold a medicament comprising a cartridge top and a cartridge bottom which are moveable relative to one another by a translational motion; at least one inlet port to allow flow into the enclosure, and at least one dispensing port to allow flow out of the enclosure; said at least one inlet port is configured to direct at least a portion of the flow entering the at least one inlet port at the at least one dispensing port within the enclosure in response to a pressure differential.
The differences between claimed subject matter and the reference claims include lack of disclosure in the reference claims of the breath powdered inhaler and the Tmax or percent emitted powder. However, one of ordinary skill in the art would have been motivated to incorporate such limitations and ranges from the teachings of the prior art for their advantage and contribution to the efficacy of the delivery. Steiner et al discloses particles of FDKP and insulin wherein the peak is achieved in less than 30 minutes and the inhaler is breath activated. As such the combination of teachings would have lead one of ordinary skill in the art to the claimed invention.
Claims 1, 3-5, 7, 10-14 and 16-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-5, 8 and 11-13 of U.S. Patent No. 9,662,461. Although the claims at issue are not identical, they are not patentably distinct from each other because the examined claims would have been obvious over the reference claims.
Instant claim 1 is delineated above.
Reference claims 1, 3-4, 7, 10 and 13-14 recite a dry powder inhaler comprising: at least one rigid air conduit and a housing configured to accept a cartridge, the cartridge comprising a lid and a movable container having a dry powder, the container configured to move relative to the cartridge lid from a storage position to a dispensing position to form a flow path between one or more inlet ports and one or more dispensing ports within the inhaler; and wherein the dry powder inhaler is configured to emit greater than about 75% of a dry powder from the container as powder particles in a single inhalation, and the powder particles emitted have a volumetric median geometric diameter of less than about 5 microns when the single inhalation generates a peak inspiratory pressure of about 2 kPa within two seconds. The container is configured to hold a dry powder medicament including a peptide or protein including insulin and diketopiperazine.
The difference between the recited claims of the instant application and the reference claims is that the instant application claims do not expressly recite the limitations of the inhaler or an airflow whereas reference claims do. However, the recited claims of the instant application are not mutually exclusive since the inhaler of the instant application is the same as that claimed by reference claims. In other words, all the limitations of the instant claims are within the scope of reference claims.
Claims 1, 3-5, 7, 10-14 and 16-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 8,778,403. Although the claims at issue are not identical, they are not patentably distinct from each other because the examined claims would have been obvious over the reference claims.
Instant claim 1 is delineated above.
Reference claims recite a method of delivering an active agent to a patient in need thereof comprising administering a dry powder comprising microparticles of a diketopiperazine, the microparticles having been loaded with a drug or active agent, by inhalation of said dry powder by said patient. The dry powder is contained in a unit dose cartridge comprising the medicament including a peptide or protein including insulin and diketopiperazine.
The difference between the recited claims of the instant application and the reference claims is that the instant application claims do not expressly recite the limitations of the inhaler or an airflow whereas reference claims do. However, the recited claims of the instant application are not mutually exclusive since the inhaler of the instant application is the same as that claimed by reference claims. In other words, all the limitations of the instant claims are within the scope of reference claims.
Claims 1, 3-5, 7, 10-14 and 16-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-5, 8 and 11-13 of U.S. Patent No. 10,201,672. Although the claims at issue are not identical, they are not patentably distinct from each other because the examined claims would have been obvious over the reference claims.
Instant claim 1 is delineated above.
Reference claims 1, 4 and 11 recite an inhaler comprising: a housing, a mouthpiece, and a cartridge contained within the housing, the cartridge comprising two or more rigid parts; wherein at least one of the two or more rigid parts of the cartridge is a container, wherein the mouthpiece is configured to translocate the container from a powder containment position in a first location to a dosing position in a second location different than the first location by moving the container relative to another of the at least two or more rigid parts of the cartridge thereby creating an entrance into and an exit from the container when in the dosing position; wherein in the powder containment position, there is not an airflow passageway through the container; and wherein in the dosing position there is an airflow passageway through the container and 10% to 70% of total airflow through the inhaler enters and exits the cartridge. The container is configured to hold a dry powder medicament including a peptide or protein including insulin and diketopiperazine.
The difference between the recited claims of the instant application and the reference claims is that the instant application claims do not expressly recite the limitations of the inhaler or an airflow whereas reference claims do. However, the recited claims of the instant application are not mutually exclusive since the inhaler of the instant application is the same as that claimed by reference claims. In other words, all the limitations of the instant claims are within the scope of reference claims.
Claims 1, 3-5, 7, 10-14 and 16-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-5, 8 and 11-13 of U.S. Patent No. 10,744,280. Although the claims at issue are not identical, they are not patentably distinct from each other because the examined claims would have been obvious over the reference claims.
Instant claim 1 is delineated above.
Reference claims 1, 6 and 13 recite a medicament cartridge comprising: a powder container configured to include a location for a dry powder; a lid; and an internal volume, wherein the medicament cartridge is configured to include a containment configuration and a dosing configuration, wherein the lid includes a deflector or stem protruding from an undersurface facing the internal volume, wherein in the dosing configuration the deflector or stem is situated over the location for the dry powder to direct airflow entering the internal volume from a direction parallel to the lid to a substantially downward direction, to a direction substantially parallel to the lid through the location, to a direction substantially perpendicular to the lid to exit the powder container. The container is configured to hold a dry powder medicament including a peptide or protein including insulin and diketopiperazine.
The difference between the recited claims of the instant application and the reference claims is that the instant application claims do not expressly recite the limitations of the inhaler or an airflow whereas reference claims do. However, the recited claims of the instant application are not mutually exclusive since the inhaler of the instant application is the same as that claimed by reference claims. In other words, all the limitations of the instant claims are within the scope of reference claims.
Claims 1, 3-5, 7, 10-14 and 16-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 and 8-14 of U.S. Patent No. 10,751,488. Although the claims at issue are not identical, they are not patentably distinct from each other because the examined claims would have been obvious over the reference claims.
Instant claim 1 is delineated above.
Reference claims 1, 5 and 8 recite a medicament cartridge for an inhaler, comprising: a cartridge disk including two or more containers configured to hold a medicament; …… . The container is configured to hold a dry powder medicament including a peptide or protein including insulin and diketopiperazine.
The difference between the recited claims of the instant application and the reference claims is that the instant application claims do not expressly recite the limitations of the inhaler or an airflow whereas reference claims do. However, the recited claims of the instant application are not mutually exclusive since the inhaler of the instant application is the same as that claimed by reference claims. In other words, all the limitations of the instant claims are within the scope of reference claims.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Gelber et al (US 20060153778).
Gelber et al teach compositions for minimizing the accrual of inhaled insulin in the lungs of a patient after administration of an inhaled insulin composition. The said inhalable insulin composition is a dry powder. Preferably, the insulin is complexed with a diketopiperazine, such as fumaryl diketopiperazine (See [0014]-[0018]). The said formulation is administered directly as a dry powder, such as by inhalation using, for example, dry powder inhalers known in the art (See [0084]).
Gelber et al recite that “As used herein, the term "TechnosphereTM/Insulin" refers to fumaryl diketopiperazine complexed with insulin. TechnosphereTM are microparticles (also referred to herein as microspheres) formed of diketopiperazine that self-assembles into an ordered lattice array at particular pHs, typically a low pH. They typically are produced to have a mean diameter between about 1 and about 5 µm” (See [0034]). It is further disclosed that the said TechnosphereTM/insulin dry powder, pulmonary insulin is delivered via the small MannKindTM inhaler (See [0106]).
Gelber et al then disclose insulin AUC (0-last) in lung (FIG. 3A) and serum (FIG. 3B) following inhalation of 3 Units TechnosphereTM/Insulin. Table 2 shows the AUC values in the lung and serum of the rat which include 67104 mIU*min/rat in day 1 in the lung.
Gelber et al does not expressly disclose the inhaler comprising a flow path through a container and lack a specific disclosure on the AUC 0-2hr being from 160 to 1,000 µU*min/mL per unit of insulin emitted. However, the device disclosed by Steiner et al would be able to achieve the said results.
Response to Arguments
Applicant’s arguments, see Remarks filed on 10/17/25, with respect to rejection of claims under 35 USC §103 have been fully considered and are persuasive. The said rejections have been withdrawn.
Applicants request for the double patenting rejections of record to be held in abeyance is acknowledged. However, this request to hold a rejection in abeyance is not a proper response to a rejection. Rather, a request to hold a matter in abeyance may only be made in response to an objection or requirements as to form (see MPEP 37 CFR 1.111(b) and 714.02). Accordingly, the rejection will be maintained until a terminal disclaimer is filed or claims are amended to obviate the rejection.
Claims 1, 3-5, 7, 10-14 and 16-17 are rejected. Claim 15 is withdrawn.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mina Haghighatian whose telephone number is (571)272-0615. The examiner can normally be reached on M-F, 7-5 EST.
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/Mina Haghighatian/
Mina Haghighatian
Primary Examiner
Art Unit 1616