DETAILED ACTION
Claims 1-5, 7-13, 16-20 and 29 are currently pending. Claims 1-5, 7-13, 16-18 and 20 are currently under examination.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 05/11/2026 is acknowledged.
Claim 19 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a non-elected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/11/2026.
Applicant’s election without traverse of peptide as the effective ingredient and water/ethanol mixture as the solvent where the peptide is dissolved as the starting material in the reply filed on 05/11/2026 is acknowledged.
Claim 29 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/11/2026.
Priority
The instant application is a continuation of 18/460,833, filed 09/05/2023, which is a continuation of 17/154,610, filed 01/21/2021, which is a continuation of 16/410,189, filed 05/13/2019, which is a continuation of 15/479,137, filed 04/04/2017, which is a continuation of 14/603,211, filed 01/22/2015, which is a divisional of 12/665,386, filed 06/02/2010, which is a national stage entry of PCT/US08/67766, filed 06/20/2008, which claims priority to provisional 60/945,737, filed 06/22/2007.
Information Disclosure Statement
Applicant’s Informational Disclosure Statement, filed on 12/18/2024 has been considered. Please refer to Applicant's copy of the 1449 submitted herein.
Claim Objections
Claims 9 and 18 are objected to because of the following informalities:
Claim 9 contains the limitation of 200 m2/gr, wherein the use of gram for the abbreviation of gr would be clearer.
Claim 18 contains the limitation “further comprising further comprising”, a typographical error to include the further comprising twice in a row.
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 1, 3-13, 16-18 and 20 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.
Claims 1 and 20 refers to the method of preparing micron sized and submicron sized particles, but the last step of the method of claim 1 and 20 refers to the formation of a thin film with a thickness. It is unclear if the method is drawn to making a particle or a film, and if a method step is missing to result in the particle form. Claims 1 and 20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential steps, such omission amounting to a gap between the steps. See MPEP § 2172.01. The omitted steps are: The formation of the micron sized or submicron-sized peptide particles. Claims 3-13, 16-18 are further rejected as not curing the ambiguity of claims 1 and 20.
Regarding claims 9-13, claims 9-13 are dependent on claim 0. Claim 0 does not exist, thus the claims have unclear metes and bounds and it is not clear what the claim dependency is. For examination purposed claims 9-13 will be examined as dependent on claim 1.
Regarding claim 9, the limitation of 200 m2/gr. There is reference to surface area, but no reference to surface area to mass of any kind. Clarification is request as to what the units of measurement are directed to in the claims, m2/gr. What is the gram of?
Regarding claim 10-11, the limitation of wherein the particle has less than 50% of the peptide at the particle surface, less than 25, 15, 10 or 5% of the peptide at the surface is unclear, as claim 1-2 contains only solvent and peptide, wherein the solvent is removed to form the particle. It is therefore unclear how the particle surface can be less than 50% of the only ingredient required, leading to unclear metes and bounds of the claim, and may include a missing essential ingredient.
Regarding claim 13, the limitation of where the particle fibers are part of the particle structure. Is it in addition to the particle, do the particles form a fiber structure?
Regarding claim 16, the limitation of “wherein an aggregation of the peptide of less than 3%”. It is unclear what the 3% is referring to, 3% of the total amount of peptide is in aggregation?
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 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, 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 negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 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 pre-AIA 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 pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 1-5, 7-13, 16-18 and 20 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Overhoff (European Journal of Pharmaceutics and Biopharmaceutics 65 (2007) pgs. 57-67, Applicant provided) in view of US 2004/0022861.
Regarding claim 1-5, 7-9, 12-13, 16-18 and 20, the limitation of a method for preparing micron-sized or submicron-sized particles comprising: dissolving the active in one or more solvents; spraying or dripping solvent droplets such that peptide is exposed to a vapor-liquid interface of less than 500 cm-1 area/volume and contacting the droplet with a freezing surface that has a temperature differential of at least 30 degrees C between the droplets and the surface, wherein the surface freezes the droplet into a thin film with a thickness of less than 500 micrometers and a surface area to volume between 25 to 500 cm-1 is met by Overhoff teaches ultra-rapid freezing technology to produce high surface area powders composed of solid solutions of active pharmaceutical ingredient and a polymer stabilizer. A solution of API and polymer excipients is spread on a cold solid surface to form a thin film that freezes in 50 ms to 1s. The particle powder is taught to be submicron primary particles with a simple ultra-rapid freezing process (abstract). Active and PVP are taught as dissolved in t-but, solutions were applied to cryogenic solid substrate cooled to a temperature range of 193-243 K, collected and lyophilized using a benchtop lyophilizer (page 58, 2.2). Single droplets were taught as dropped onto the cryogenically cooled surface (page 59, 2.4). The complete spreading of the ACN occurred within the first 10 ms interval indicating that the time of droplet spreading was much less than the freezing time. The surface area is taught to be 25.93 m2/g (Table 1). Compact aggregates of uniform nanoparticles with diameter of about 100 nm or smaller is taught (page 62, second column, second paragraph), teaching low aggregation and reading on claim 16. The limitations of the specific vapor-liquid interface, and surface are to volume are optimizable parameters, wherein the conditions such as the drop dropping height, temperature of the substrate, freeze and spread time of the droplets are taught to be tested and optimizable parameters. As MPEP 2144.05 recites “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine optimization”.
Regarding claims 10-11, the limitation of wherein the particle has less than 50% of the peptide at the surface at the particle surface, less than 25%, 15%, 10% or 5% of the peptide at the surface is met by Overhoff teaching the particle to be formed by dissolving DAN and PVP at a 1:2 ratio (page 58, 2.2), thus would be less than 50% of the particle as it is less than 50% of the ingredients of the particle. Further the amount of polymer to drug ratio is an optimizable parameter. As MPEP 2144.05 recites “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine optimization”.
Overhoff does not specifically teach a peptide.
The ‘224 publication teaches spherical nanocrystalline composite particles of proteins or compositions (abstract). The nanoparticles are taught for biomedical applications and are useful for delivery of large amounts of proteins in a small volume [0003]. Protein drugs are desired as dry powder formulation [0007]. A number of methods have been used to prepare the particles including spray drying, lyophilization and jet milling [0008]. Proteins are taught to include peptides ([0017], [0059], [0088]) which may be aggregated or non-aggregated [0019]. The particles are taught to be 0.04-300 microns in diameter [0058]. Polyvinyl pyrrolidone is taught to be a polymer used in the particle [0065]. The SSPs are formed using solvents such as t-butanol [0087].
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use peptides as taught by the ‘224 publications as the active ingredient in the particles taught by Overhoff because the ‘224 publication teaches the desire to deliver peptides from particles and Overhoff teaches method of forming particles for drug delivery. One of ordinary skill in the art before the filing date of the claimed invention would be motivated to use the peptides in the particles taught by Overhoff because the ‘224 publication teaches peptides used as dry powders in biomedical applications and Overhoff teaches the formation of powders composed of solid solutions of an active pharmaceutical ingredient and polymer stabilizer using a simple method. One of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success as Overhoff an the ‘224 publication are both directed to the formation of dry powders of an active agents wherein t-butanol is taught to be used as a solvent and PVP is taught to be used as a polymer for the formation of the drug delivery particles, thus teaching dry particle formation containing the same ingredients.
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 1-5, 7-13, 16-18 and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 8,968,786. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘786 patent teaches a method of preparing a thin film comprising dissolving a peptide in a solvent, spraying or dripping solvent droplets with a vapor to liquid interface of less than 500 cm-1 and contacting the droplets with a freezing surface that has a temperature differential of at least 30 degrees C between the droplet and the surface, wherein the surface freezes the droplet into a thin film with a thickness of less than 500 micrometers and a surface area to volume between 25-500 cm-1 wherein particles are formed from removing the solvent, having an overlapping freezing time, droplet diameter, surface area per weight and % protein in the surface overlapping with the instant claims.
Claims 1-5, 7-13, 16-18 and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 9,622,974 in view of US 2004/0219224. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘974 patent teaches a method of preparing a thin film comprising dissolving a water soluble effective ingredinet in a solvent, spraying or dripping solvent droplets with a vapor to liquid interface of less than 500 cm-1 and contacting the droplets with a freezing surface that has a temperature differential of at least 30 degrees C between the droplet and the surface, wherein the surface freezes the droplet into a thin film with a thickness of less than 500 micrometers and a surface area to volume between 25-500 cm-1 wherein particles are formed from removing the solvent, having an overlapping freezing time, droplet diameter, surface area per weight and % protein in the surface overlapping with the instant claims. The ‘974 patent does not specifically teach a peptide. The ‘224 publication teaches spherical nanocrystalline composite particles of proteins or compositions (abstract). The nanoparticles are taught for biomedical applications and are useful for delivery of large amounts of proteins in a small volume [0003]. Protein drugs are desired as dry powder formulation [0007]. A number of methods have been used to prepare the particles including spray drying, lyophilization and jet milling [0008]. Proteins are taught to include peptides ([0017], [0059], [0088]) which may be aggregated or non-aggregated [0019]. The particles are taught to be 0.04-300 microns in diameter [0058]. Polyvinyl pyrrolidone is taught to be a polymer used in the particle [0065]. The SSPs are formed using solvents such as t-butanol [0087]. It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use peptide as taught by the ‘224 publication in particles of the ‘974 patent as the ‘224 patent teaches the desire to form particle of peptides for drug delivery and the ‘974 patent teaches preparation of micron sized particle comprising a water soluble active agent.
Claims 1-5, 7-13, 16-18 and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 10,285,945. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘945 patent teaches a method of preparing a thin film comprising dissolving a peptide in a solvent, spraying or dripping solvent droplets with a vapor to liquid interface of less than 500 cm-1 and contacting the droplets with a freezing surface that has a temperature differential of at least 30 degrees C between the droplet and the surface, wherein the surface freezes the droplet into a thin film with a thickness of less than 500 micrometers and a surface area to volume between 25-500 cm-1 wherein particles are formed from removing the solvent, having an overlapping freezing time, droplet diameter, surface area per weight and % protein in the surface overlapping with the instant claims.
Claims 1-5, 7-13, 16-18 and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 10,898,437. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘437 patent teaches a method of preparing a thin film comprising dissolving a peptide in a solvent, spraying or dripping solvent droplets with a vapor to liquid interface of less than 500 cm-1 and contacting the droplets with a freezing surface that has a temperature differential of at least 30 degrees C between the droplet and the surface, wherein the surface freezes the droplet into a thin film with a thickness of less than 500 micrometers and a surface area to volume between 25-500 cm-1 wherein particles are formed from removing the solvent, having an overlapping freezing time, droplet diameter, surface area per weight and % protein in the surface overlapping with the instant claims.
Claims 1-5, 7-13, 16-18 and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 11,759,427. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘427 patent teaches a method of preparing a thin film comprising dissolving a peptide in a solvent, spraying or dripping solvent droplets with a vapor to liquid interface of less than 500 cm-1 and contacting the droplets with a freezing surface that has a temperature differential of at least 30 degrees C between the droplet and the surface, wherein the surface freezes the droplet into a thin film with a thickness of less than 500 micrometers and a surface area to volume between 25-500 cm-1 wherein particles are formed from removing the solvent, having an overlapping freezing time, droplet diameter, surface area per weight and % protein in the surface overlapping with the instant claims.
Conclusion
No claims are allowed.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNDSEY MARIE BECKHARDT whose telephone number is (571)270-7676. The examiner can normally be reached Monday-Thursday 9am to 4pm and Friday 9am to 2pm.
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/LYNDSEY M BECKHARDT/ Examiner, Art Unit 1613
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