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 1-2, 4-9, 20-23, 26-29, 34-37 have been presented for examination on the merits. The amended claim set was filed on 12/10/24.
Claim objection
Claim 1 recites “… laser diffraction and, and the coating…”. It appears this is a typographical error.
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.
Claims 22-23, 29 and 36 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 broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 22 recites the broad recitation carbohydrate, and the claim also recites an alginate which is the narrower statement of the range/limitation. Similarly claim 23 recites the broad recitation cellulose, and the claim also recites microcrystalline cellulose, hydroxypropyl methylcellulose, hydroxypropyl methylcellulose acetate succinate which are the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 23 is also indefinite for reciting sorbitol twice in the Markush.
Claim 29 is indefinite for reciting a one-sided range of at least 1%. The said range encompasses 100% which is not possible since the powdery formulation comprises excipients and coating material as well. There is also no evidence that Applicants envisioned or disclosed a formulation comprising more than 10% of epinephrine (See Spec at [0112]).
Claim 36 is indefinite for reciting that the administration is conducted … or more than four times per day. this is indefinite because “more than four times” encompasses 50, 100 or 200 times per day which is not possible or envisioned. Accordingly, it would not be clear to one of ordinary skill in the art as to how many times per day the formulation can be administered.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 2 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 2 recites that each particle of the plurality of spray dried particles comprises the epinephrine or a pharmaceutically acceptable salt thereof. However, this is already recited in claim 1 and as such claim 2 fails to further limit the parent claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Applicant’s claims,
Claim 1, is the broadest claim and is drawn to: A powdery pharmaceutical composition, comprising: i) particles of a pharmaceutically acceptable excipient; and ii) a plurality of spray dried particles, each particle of the plurality of spray dried particles comprising: an epinephrine or a pharmaceutically acceptable salt thereof substantially encapsulated in a coating material, wherein: within the plurality of spray dried particles at least a portion of the spray dried particles comprising the epinephrine or the pharmaceutically acceptable salt thereof substantially encapsulated in the coating material, individually have a particle diameter of about 30 micrometer, as measured by a particle analyzer using laser diffraction and, the coating material comprises a hydroxypropyl methylcellulose (HPMC), a hydroxypropyl methylcellulose acetate succinate (HPMCAS), a povidone, a copovidone or any combination thereof.
Claim 35 is drawn to a method of treating an allergic reaction.
Claim interpretation:
Specification defines “substantially encapsuled” as a qualitative condition that exhibits an entire or nearly total range or degree of a feature or characteristic of interest. In some cases, substantially may refer to at least about: 70%, ….. 99%, or 100% of the total range or degree of a feature or characteristic of interest.
The term “spray-dried particles” is a product-by process limitation.
Claims 22 and 23 list a number of species, but the claims do not use the Markush type language and use the term “comprising” which does not limit the excipient or carbohydrate to those listed.
Limitations such as “contained in a capsule”, “capsule is about one quarter to about one half, by volume, filled…” or “contained in an inhaler unit” are relevant to the storage of the claimed powder formulation (after it has been produced) and do not materially affect the scope of the composition or claim 1.
Similarly, the storage limitations of claim 26 do not materially affect the scope of claimed composition.
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 1-2, 4-5, 7-9, 20-23, 26-29, 34-37 are rejected under 35 U.S.C. 103 as being unpatentable over Fleming (US 20170368000) in view of Wilkhu et al (11,160,757) and/or Appel et al (US 20090142404).
Fleming teaches intranasal formulation of epinephrine for the treatment of anaphylaxis (See Title and abstract).
Regarding claims 1, 4, 22-23 and 27, Fleming teaches a dry powder preparation, comprising epinephrine in amount less than 100 mg, preferably from 10 to 20 mg for intranasal administration, and more preferably in amounts ranging from 0.05 mg to 10 mg (See [0017], [0018], [0020]-[0021] and claim 13).
The said intranasal epinephrine composition further comprise one or more additional agents selected from the group of epinephrine potentiator, a mucosal permeation enhancer, an agent that reduces mucosal transit time, an agent that increases mucosal absorption or adhesion or transport, surfactants, chelators, excipients, stabilizers, preservatives, thickening agents, humectants, antihistamines, solubilizing agents, taste and smell masking agents, colorants, or any combination thereof. Examples of such excipient include lactose, sorbitol, glycerol, etc, (See [0019], [0021]-[0022], [0051], [0058] and [0118]).
Fleming also teaches that the said composition is a dry powder formulation, including powder microspheres, coated powder microspheres (See [0066]). The average particle diameter of each of the ingredient is within 30 μm (See [0118]).
Regarding claims 1 and 7, Fleming discloses that the epinephrine also contains a vasodilation agent and can be blended as a co-mixture; and can also be envisioned to be further blended with lactose particles in order to provide a particle size suitable for nasal administration (See [0129]).
Regarding claims 4-5, 8-9, 20-21, Fleming teaches that the said composition may be administered using a nasal metered dose spray, metered dose inhaler or measured dose inhaler (See [0024]). The powder compositions, in preferred embodiments, may be presented in a sterile unit dosage form, for example, in capsules, cartridges, or blister packs, from which the powder may be administered with the aid of a dry powder dispenser or by numerous other nasal delivery methods well known to those skilled in the art (See [0071]).
Regarding claim 28, Fleming teaches that the anti-anaphylactic agent, epinephrine, may be epinephrine hydrochloride, epinephrine free base, epinephrine maleate, epinephrine bitartrate, etc, (See [0034]).
Regarding claim 29, Fleming teaches that, epinephrine represented in the dry powder formulation is between 0.25% and 50% (See [0069]).
Regarding a kit comprising the said composition in a package of claim 34, Fleming teaches that the said formulation can then be packaged into vials or nasal spray devices for delivery into nasal mucosa of test subjects (See [0118]).
Regarding claims 35-37, Fleming clearly teaches that the said formulations are for treating anaphylaxis (an allergic reaction). The dosage may be adjusted according to the weight of the patient and repeated a number of times (See [0017]-[0018], [0026]-[0027] and [0030]).
Fleming teaches that the particles may be coated particles, but is silent with regard to the coating material of claim 1. Fleming also discloses spray drying but is silent with regard to the spray dried particles. These modifications would have been obvious in view of the teachings and suggestions provided by the references Wilkhu et al and/or Appel et al.
Wilkhu et al teach pH dependent release coated microparticle cannabionoid formulation.
Regarding the coating material of claim 1, Wilkhu et al teach that the pH dependent release polymer is selected from the group consisting of: hydroxypropyl methyl cellulose acetate succinate (HPMCAS), hydroxypropyl methyl cellulose phthalate (HPMCP), polyvinyl acetate phthalate (PVAP), shellac, gellan gum, zein, etc (See Col. 2, lines 53-67 and claim 4).
The said microparticulates may be formulated in any suitable formulation, including a powder, a solid powder filled capsule, an extrudate, a nasal spray, etc, (See paragraph bridging columns 22-23 and Col. 32, lines 42-50).
Wilkhu et al teach a method of preparing the said microparticulate cannabinoid containing formulation comprising spray drying the formulation (See Col. 3, lines 64-67 and Example 3).
Appel et al teach a dosage form comprising a low-solubility drug, and a precipitation-inhibiting polymer. The drug is in a solubility-improved form and in the form of particles at least partially coated with the precipitation-inhibiting polymer including HPMCAS (See abstract).
Exemplary coating polymers include hydroxypropyl methyl cellulose acetate succinate (HPMCAS), hydroxypropyl methyl cellulose phthalate (HPMCP), hydroxypropyl methyl cellulose acetate, hydroxypropyl methyl cellulose, hydroxypropyl cellulose, methyl cellulose, hydroxyethyl methyl cellulose, hydroxyethyl cellulose acetate, and hydroxyethyl ethyl cellulose (See [0058], [0061], [0065]-[0066]).
Appel et al teach that one method to reduce particle size is by melting or spray drying to form a powder (See [0033], [0078]-[0079] and claim 12).
Appel et al further disclose that the said formulations may comprise additives including fillers, or diluents include lactose, mannitol, xylitol, dextrose, sucrose, sorbitol, microcrystalline cellulose, powdered cellulose, starch, hydroxypropyl methyl cellulose, crospovidone (polyvinylpolypyrrolidone), sodium alginate, etc, (See [0089]-[0091]).
It would have been prima facie obvious to a person of ordinary skilled in the art at the time the invention was made to have combined the teachings of Wilkhu et al and/or Appel et al with that of Fleming to arrive at the instant invention. It would have been obvious to do so because Fleming teaches a dry powder formulation comprising epinephrine and one or more suitable excipients and teaches that the said particles may be in the form of coated microparticles. Fleming does not how ever disclose a suitable material for coating such particles. Thus, one of ordinary skill in the art wishing to follow Fleming’s teachings to make coated particles would need to look in the art for suggestions on suitable coating materials. The person of ordinary skill in the art would find such suggestion in the teachings of Wilkhu et al and/or Appel et al as they teach the suitable material for coating a particle and the advantage of doing so. For example, Wilkhu et al teach that the coating material provides for a pH dependent release of the active agent and Appel teach that the coating material is a precipitation-inhibiting polymer.
That is, the claims would have been obvious because a person of ordinary skill has good reasons to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense.
Claims 1-2, 4-9, 20-23, 26-29, 34-37 are rejected under 35 U.S.C. 103 as being unpatentable over Temtsin-Krayz (WO 2019038756 or US 20200368156) (citations from the US document) in view of Batycky et al (US 20170119699), Wilkhu et al (11,160,757) and/or Appel et al (US 20090142404).
Temtsin-Krayz teaches a pharmaceutical composition in a form of dry powder for intranasal administration, comprising solid particles of at least one active agent and solid particles of a diluent, said pharmaceutical composition being substantially free of excipients other than the solid diluent, wherein said pharmaceutical composition having at least 90% of the particles of said at least one active agent with a mean particle size of 10-30 microns and the particles of said diluent have a mean particle size of 30-200 microns. The said formulation prepared by spray drying method to prepare the said dry powder (See abstract).
Further, regarding claims 1-2, 4-9, it is disclosed that the active agent may be epinephrine, (See [0018], [0093] and claim 4), the particles are spray dried and that the powders may be powder microspheres, coated powder microspheres, liposomal dispersions and combinations thereof (See [0034] and [0100]).
Regarding claims 1 and 22-23, Temtsin-Krayz teaches that the said solid diluent is selected from lactose monohydrate or a lactose monohydrate functional analogue, such as lactose, cellulose and derivatives, starch and derivatives, sorbitol, mannitol, maltitol, xylitol or mixtures thereof, preferred solid diluent being lactose monohydrate (See [0035] and [0095]).
Temtsin-Krayz teach that the formulations are administered vi a nasal spray or inhaler device (See [0102]-[0103]).
Regarding the dosing frequency in claim 36, a method of treatment is disclosed wherein the therapeutically effective dose of at least one active agent is administered once daily (See [0106]).
The examined claims differ from the teachings of Temtsin-Krayz in that the coated microparticles is disclosed but the coating material is not. Temtsin-Krayz also does not expressly teach a method of treating an allergic reaction including anaphylaxis. These are well known in the art as taught by Batycky et al, Wilkhu et al and/or Appel et al.
Batycky et al teach particles for delivery of epinephrine to the respiratory system and methods for treating a patient in need of epinephrine. The particles and respirable compositions comprising the said particles comprise the bioactive agent epinephrine, or a salt thereof, as a therapeutic agent. The particles are preferably formed by spray drying. Preferably, the particles and the respirable compositions are substantially dry (See abstract).
Regarding claim 1, Batycky et al teach spray-dried particles of epinephrine or a salt thereof and at least one excipient (See [0008]-[0009]).
Regarding claims 1 and 22-23, it is disclosed that the particles can also include other materials such as, for example, buffer salts, sugars, cholesterol, dextran, polysaccharides, lactose, mannitol, maltodextrin, cyclodextrins, proteins, fatty acids, fatty acid esters, inorganic compounds, phosphates, lipids, etc (See [0087]).
Regarding claims 35-37, Batycky et al disclose a method for treating a patient in need of epinephrine, the method comprising administering an effective amount of substantially dry particles to the respiratory system of the patient, the particles comprising epinephrine, or a salt thereof, wherein the patient needs treatment for anaphylaxis or allergic conditions (See [0010], [0012]-[0013] and [0162]-[0163]).
Regarding claims 5, 8-9, 20-21 and 26, it is disclosed that epinephrine containing dry powder particles will allow patients to carry a convenient, compact inhaler, a dry powder inhaler and reliably self-administer epinephrine non-invasively. The inhalers contain receptacles such as capsules which contain the powdery formulation (See [0038], [0187], [0191], [0193]). It is further disclosed that generally, filling the receptacle with powder can be carried out by methods known in the art. The particles, powder or respirable composition which is enclosed or stored in a receptacle has a mass of at least about 1.0 mg, preferably, at least about 5.0 milligrams or, alternatively, up to about 10, 20, 25, 30, or 50 milligrams. Generally, the receptacle and the inhalers are used in a temperature range of about 5 to about 35° C. and at about 15 to about 85% relative humidity (See [0194]).
Further, regarding the stability/storage conditions in claim 26, it is disclosed that the said particles include epinephrine that is generally stable over a period of at least about 1 year. In one embodiment, at least about 90%, e.g., about 95%, of epinephrine contained in the particles is not degraded as measured by HPLC over a period of at least about 1 year (See [0137]).
Regarding claim 28, Batycky et al teach that the said particles can comprise salts of epinephrine, including, epinephrine hydrochloride, epinephrine bitartrate or epinephrine free base (See [0044]).
Regarding claim 29, Batycky et al disclose that the said epinephrine or salt thereof is present in the formulation in an amount of 1% to about 95%, about 1% to about 45% or about 1% to about 30% by weight (See [0046] and claims 2-4).
The teachings of Wilkhu et al and Appel et al are delineated above and incorporated herein.
It would have been prima facie obvious to a person of ordinary skilled in the art at the time the invention was made to have combined the teachings of Batycky et al, Wilkhu et al and/or Appel et al with that of Temtsin-Krayz to arrive at the instant invention. It would have been obvious to do so because Temtsin-Krayz teaches a dry powder formulation comprising epinephrine and one or more suitable excipients and teaches that the said particles may be in the form of coated microparticles. Temtsin-Krayz does not however disclose a suitable material for coating such particles. Thus, one of ordinary skill in the art wishing to follow Fleming’s teachings to make coated particles would need to look in the art for suggestions on suitable coating materials. The person of ordinary skill in the art would find such suggestion in the teachings of Wilkhu et al and/or Appel et al as they teach the suitable material for coating a particle and the advantage of doing so. For example, Wilkhu et al teach that the coating material provides for a pH dependent release of the active agent and Appel teach that the coating material is a precipitation-inhibiting polymer.
That is, the claims would have been obvious because a person of ordinary skill has good reasons to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense.
Additionally, Batycky et al teach powdery formulation comprising epinephrine wherein the said powder may be delivered via an inhaler containing a unit dose including a capsule for holding and delivering the powder to the subject in need of a treatment including anaphylaxis.
Therefore, the combination of references would have led one of ordinary skill in the art to the same formulation and method as claimed with a reasonable expectation of success.
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 1-2, 4-9, 20-23, 26-29, 34-37 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6, 14-15, 18, 20-21, 23, 25, 28-29, 31, 35-38 of copending Application No. 18/031,898 (US 20240050450) in view of Tamtsin-Krayz (WO 2019038756 or US 20200368156).
The Obviousness Double Patenting rejection is appropriate because while the conflicting claims are not identical, the examined claims are not patentably distinct from the reference claims and would have been obvious over the reference claims in view of Tamtsin-Krayz.
The examined claims are delineated above.
The reference claims are also directed to a powdery pharmaceutical composition, comprising: i) particles of a pharmaceutically acceptable excipient; and ii) a plurality of spray dried particles, each particle of the plurality of spray dried particles comprising a cannabinoid or a pharmaceutically acceptable salt thereof, substantially encapsulated in a coating material, wherein within the plurality of spray dried particles, the plurality of spray dried particles individually have a particle diameter ranging from about 1 micrometer to about 10 micrometers, as measured by a particle analyzer using laser diffraction and, wherein the coating material comprises a hydroxypropyl methylcellulose (HPMC), a hydroxypropyl methylcellulose acetate succinate (HPMCAS), a cyclodextrin, a maltodextrin, a povidone, a copovidone or any combination thereof.
The differences between the recited claims of the instant application and the recited claims of copending Application are 1) the active agent and 2) the particle diameter. That is, the instant application claims are directed to a composition comprising epinephrine while the reference claims recite a cannabinoid. Also, the particle diameter of the instant claimed composition is about 30 micrometers while the reference claims recite a diameter of from 1 to 10 micrometer.
However, the examined claims would have been obvious over the reference claims in view of the knowledge available to one of ordinary skill in the art, especially Tamtsin-Krayz. Tamtsin-Krayz teach a powdery formulation comprising an active agent and suitable excipients wherein the active agent may be epinephrine, a cannabinoid (cannabis active compounds), etc. It is further recited that the particle diameter may be from 10-30 micrometer and that for nasal administration they should not be smaller than 10 micrometers. Thus, the combination of references fully advises one of oriental skill in the art as to the suitable particle size range for pulmonary and nasal administration.
Thus, it is haled that the recited claims of the instant application are not mutually exclusive of the reference claims in view of the knowledge available to one of ordinary skill in the art and especially in view of Tamtsin-Krayz.
This is a provisional nonstatutory double patenting rejection.
Claims 1-2, 4-9, 20-23, 26-29, 34-37 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 6, 24-25, 27-28, 31-34, 36-37, 41 and 45 of copending Application No. 18/027,655 (US 20230372345) in view of Tamtsin-Krayz (WO 2019038756 or US 20200368156).
The Obviousness Double Patenting rejection is appropriate because while the conflicting claims are not identical, the examined claims are not patentably distinct from the reference claims and would have been obvious over the reference claims in view of Tamtsin-Krayz.
The examined claims are delineated above.
The reference claims are also directed to an inhalable powdery pharmaceutical composition, comprising: i) particles of a pharmaceutically acceptable excipient comprising a lactose or a pharmaceutically acceptable salt thereof, which have an average particle diameter ranging from about 60 micrometers to about 80 micrometers, as measured by a particle analyzer using laser diffraction; and ii) a plurality of spray dried particles, each particle of the plurality of spray dried particles comprising sildenafil, an ester thereof, or a pharmaceutically acceptable salt thereof, substantially encapsulated in a coating material, wherein within the plurality of spray dried particles at least a portion of the spray dried particles comprising the sildenafil, the ester thereof, or the pharmaceutically acceptable salt thereof, substantially encapsulated in the coating material, individually have a particle diameter ranging from about 1 micrometer to about 10 micrometers, as measured by a particle analyzer using laser diffraction and, the coating material comprises a hydroxypropyl methylcellulose acetate succinate (HPMCAS),
The differences between the recited claims of the instant application and the recited claims of copending Application are 1) the active agent and 2) the particle diameter. That is, the instant application claims are directed to a composition comprising epinephrine while the reference claims recite sildenafil. Also, the particle diameter of the instant claimed composition is about 30 micrometers while the reference claims recite a diameter of from 1 to 10 micrometer.
However, the examined claims would have been obvious over the reference claims in view of the knowledge available to one of ordinary skill in the art, especially Tamtsin-Krayz. Tamtsin-Krayz teach a powdery formulation comprising an active agent and suitable excipients wherein the active agent may be epinephrine, sildenafil, etc. It is further recited that the particle diameter may be from 10-30 micrometer and that for nasal administration they should not be smaller than 10 micrometers. Thus, the combination of references fully advises one of oriental skill in the art as to the suitable particle size range for pulmonary and nasal administration.
Thus, it is haled that the recited claims of the instant application are not mutually exclusive of the reference claims in view of the knowledge available to one of ordinary skill in the art and especially in view of Tamtsin-Krayz.
This is a provisional nonstatutory double patenting rejection.
Claims 1-2, 4-9, 20-23, 26-29, 34-37 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8, 10-14, 16, 29-30, 32, 36, 44, 48-49 of copending Application No. 18/265,464 (US 20240041782) in view of Tamtsin-Krayz (WO 2019038756 or US 20200368156).
The Obviousness Double Patenting rejection is appropriate because while the conflicting claims are not identical, the examined claims are not patentably distinct from the reference claims and would have been obvious over the reference claims in view of Tamtsin-Krayz.
The examined claims are delineated above.
The reference claims are also directed to a pharmaceutical or dietary supplement composition, in unit dose form, comprising: a first active ingredient or a pharmaceutically acceptable salt thereof comprising a plurality of spray dried particles, each particle of the plurality of spray dried particles comprising a cannabinoid or a pharmaceutically acceptable salt thereof, substantially encapsulated in a coating material; wherein within the plurality of spray dried particles the plurality of spray dried particles individually have a particle diameter ranging from about 50 micrometers to about 150 micrometers, as measured by a particle analyzer using laser diffraction; wherein the coating material comprises a hydroxypropyl methylcellulose (HPMC), a hydroxypropyl, methylcellulose acetate succinate (HPMCAS), a maltodextrin, a povidone, a copovidone or any combination thereof; and wherein the plurality of spray dried particles are at least partially surrounded by a first capsule and a second capsule, and wherein the first capsule is surrounded by the second capsule.
The differences between the recited claims of the instant application and the recited claims of copending Application are 1) the active agent and 2) the capsules. That is, the instant application claims are directed to a composition comprising epinephrine while the reference claims recite a cannabinoid. Also, the reference claims recite that the particles are at least partially surrounded by a first capsule and a second capsule, a limitation not expressly recited in the examined claims.
However, the examined claims would have been obvious over the reference claims in view of the knowledge available to one of ordinary skill in the art, especially Tamtsin-Krayz. Tamtsin-Krayz teach a powdery formulation comprising an active agent and suitable excipients wherein the active agent may be epinephrine, a cannabinoid (cannabis active compounds), etc. Thus, it would be obvious to select a different active agent for the same formulations as taught by the references. Regarding the first and second capsule, it is noted that while the examined claims do not expressly recite this limitation, they do encompass it. It is further noted that both examined claims and reference claims recite that the coating material may be a combination of components and since the claims are drawn to an encapsulated particle, the capsule can be interpreted as referring to the encapsulation.
Thus, it is haled that the recited claims of the instant application are not mutually exclusive of the reference claims in view of the knowledge available to one of ordinary skill in the art and especially in view of Tamtsin-Krayz.
This is a provisional nonstatutory double patenting rejection.
Claims 1-2, 4-9, 20-23, 26-29, 34-37 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of copending Application No. 19/252,506 (No PG publication number assigned yet) in view of Tamtsin-Krayz (WO 2019038756 or US 20200368156).
The Obviousness Double Patenting rejection is appropriate because while the conflicting claims are not identical, the examined claims are not patentably distinct from the reference claims and would have been obvious over the reference claims in view of Tamtsin-Krayz.
The examined claims are delineated above.
The reference claims are also directed to a powdery composition, comprising: a) a plurality of encapsulated spray dried particles, wherein each particle of the plurality of spray dried particles is substantially encapsulated by a first coating, wherein the first coating is substantially encapsulated by one or more additional coatings; and b) wherein the plurality of encapsulated spray dried particles comprise a cannabinoid or a pharmaceutically acceptable salt thereof, wherein within the plurality of encapsulated spray dried particles, the plurality of encapsulated spray dried particles individually have a particle diameter ranging from about 20 micrometers to about 200 micrometers, or have a mean or median particle diameter of about 20 micrometers to about 200 micrometers, as measured by a particle analyzer using laser diffraction, i) wherein the first coating comprises a hydroxypropyl methylcellulose (HPMC), a hydroxypropyl methylcellulose acetate succinate (HPMCAS), a cyclodextrin, a maltodextrin, a povidone, a copovidone or any combination thereof; and ii) wherein the one or more additional coatings comprise an enteric coating.
The differences between the recited claims of the instant application and the recited claims of copending Application are 1) the number of coatings. That is, the instant application claims are directed to a composition comprising epinephrine while the reference claims recite a cannabinoid. Also, the reference claims recite that the particles are encapsulated by a first coating and a second coition.
However, the examined claims would have been obvious over the reference claims in view of the knowledge available to one of ordinary skill in the art, especially Tamtsin-Krayz. Tamtsin-Krayz teach a powdery formulation comprising an active agent and suitable excipients wherein the active agent may be epinephrine, a cannabinoid (cannabis active compounds), etc. Thus, it would be obvious to select a different active agent for the same formulations as taught by the references. Regarding the first and second coatings, it is noted that while the examined claims do not expressly recite this limitation, they do encompass it. It is further noted that both examined claims and reference claims recite that the coating material may be a combination of components.
Thus, it is haled that the recited claims of the instant application are not mutually exclusive of the reference claims in view of the knowledge available to one of ordinary skill in the art and especially in view of Tamtsin-Krayz.
This is a provisional nonstatutory double patenting rejection.
Claims 1-2, 4-9, 20-23, 26-29, 34-37 are rejected.
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/Mina Haghighatian/
Mina Haghighatian
Primary Examiner
Art Unit 1616