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 .
DETAILED ACTION
Claim Status
Claims 8, 9, 18-30 and 32-36 are cancelled.
Claim1 has been amended.
Claim 37 is newly added.
Claims 1-7, 10-17, 31 and 37 are pending.
Election/Restrictions
Applicant’s election of Group 1, claims 1-7 and 10-17 drawn to a lipid based particle composition in the reply filed on 13 Nov 2025 is acknowledged. The applicant further elected that the single therapeutic ingredient is fungus extract, the single lipid component is medium chain triglycerides and the single preservative is citric acid in response to the species election requirement. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
The requirement is still deemed proper and is therefore made FINAL.
Claims 1-7, 10-17, 31 and 37 are under consideration to the extent of the elected species, i.e., that the single therapeutic ingredient is fungus extract, the single lipid component is medium chain triglycerides and the single preservative is citric acid.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 09 May 2023, 10 May 2024, 19 Aug 2024, and 26 Aug 2024 are in compliance with the provisions of 37 CFR 1.97, except where noted. Accordingly, the information disclosure statement is being considered by the examiner. The foreign and NPL documents on the IDS filed 09 May 2023, except for NPL reference C3, were not considered as copies were not provided.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows: in the prior-filed application, Application No. 63/040,272, the applicant failed to provide adequate written description support for claims 1-7, 10-17, 31 and 37. Accordingly, priority cannot be granted at this time, thus claims 1-7, 10-17, 31 and 37 are granted the filing date of application 63/140,124 (21 Jan 2021).
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994)
The disclosure of the prior-filed application, Application No. 63/040,272 , fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Application ‘272 fails to provide support for extracts such as fungus extracts. Accordingly, claims 1-7, 10-17, 31 and 37 are not entitled to the benefit of the prior application.
Specification
The use of the term Tween 20 and Span 80 at [0213], which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claim 1 is objected to because of the following informalities: Claim 1 ends with “500 nm; and.” The “; and” is not needed and should be removed.
Appropriate correction is required.
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 3 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.
The term “appreciable amount” in claim 3 is a relative term which renders the claim indefinite. The term “appreciable amount” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Use of the term renders the claim unclear as to how much of the nanoparticle composition may settle and still meet the limitation of the claim.
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 1-5, 7, 10-16, 31 and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Zhou et al. (WO 2018237109, published 27 Dec 2018) in view of Kaufman et al. (US 2017/0000744, published 05 Jan 2017) as evidenced by Velez et al. (Microbiol. 13:956855).
Zhou teaches supramolecular nanoparticles based on isolated medicinal natural products (MNP) (page 4 lines 15-16). Zhou teaches that the supramolecular particles encapsulate, associate, incorporate or otherwise carry different types of drugs (page 21 lines 26-29). Zhou teaches at least five classes of MNP compounds to form supramolecular particles for delivering different types of therapeutic prophylactic or diagnostic agents (page 6 lines 3-5) including the class of phytosterols (page 22 lines 13-15) which includes cholesterol (page 30 lines 1-5). Zhou teaches the MNP compound is dissolved in an appropriate solvent to form supramolecular particles that encapsulate drugs to be delivered (page 37 lines 15-19). Zhou teaches that the inclusion of a surfactant may further improve the morphology of the formed supramolecular particles and reduce aggregation (page 38 lines 1-2). Zhou teaches that suitable surfactants include phospholipids including phosphatidylcholines such as dipalmitoylphophatidylcholine (DPPC) (page 38 lines 9-14). Zhou teaches the drug is selected based on the disease or disorder to be treated or prevented (page 53 lines 4-5) including anti-cancer agents such as paclitaxel (page 54 lines 14-21). As evidenced by Velez, paclitaxel is produced by fungi (page 01) and is thus a fungal extract. Zhou teaches that the therapeutic agent is between about 0.5 and about 50% by weight (page 95 claim 17), rendering obvious the percent of fungus extract in claims 1 and 11. Zhou teaches the inclusion of excipients such as medium chain triglycerides (page 65 lines 20-23). Zhou teaches dosage units such as suspensions and powders and reconstitutable vial (page 97 claim 30) rendering obvious the dry powder configured to be reconstituted as in instant claims 4 and 11. Zhou teaches the nanoparticles have a diameter ranging from 10 nm and 700 nm (page 38 lines 25-28) rendering obvious the particle size of the instant claims. Zhou teaches an example where 3 mg of drug loaded supramolecular nanoparticles were suspended in 1 mL buffer (page 82 lines 9-10). Assuming an aqueous buffer and approximate density of 1 g/mL the water would be at approximately 97% by weight, which is understood to render obvious the upper limit of water of “about 95%” as in claim 1. Zhou teaches a method of forming particles where an emulsion mixture is formed which forms solid particles that can be isolated (page 69 lines 7-11), rendering obvious the solid lipid nanoparticle of claim 2. Regarding claim 16, Zhou teaches the inclusion of preservatives in the particle formation (page 68 lines 15-19). Zhou further teaches the inclusion of celluloses in the dosage form (page 65 lines 20-25), rendering obvious the biomass coated with the lipid based particle as in claim 31. Zhou teaches the particles are stable in highly acidic environments (page 87 lines 26-27) and application of the compositions through various routes such as oral and nasal (page 71 lines 25-27).
Zhou does not teach the inclusion of medium chain triglycerides in the particle or the amounts of the phosphatidylcholine, sterol and lipid components. These deficiencies are made up for in the teachings of Kaufman.
Kaufman teaches phospholipid nanoparticle compositions of cannabinoids (abstract) that may be used to treat cancer ([0043]) and that increase transport across hydrophobic mucosa ([0089]). Kaufman teaches the formation of the lipid nanoparticles as solid lipid nanoparticles ([0156]). Kaufman teaches the inclusion of phophatidylcholine ([0098], [0091]) and lipids for the nanoparticle compositions such as medium chained triglycerides and cholesterol ([0175]]). Kaufman teaches a basic intranasal nanoparticle composition where the phospholipids are from 5-35% ([0238]) and the lipids are from 2-15% ([0262]) and the composition is balanced to 100% with water ([0268]). Kaufman teaches and alternative composition for oral delivery where the lipids are present from 25-75% ([0239]).
Therefore, 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 have a lipid nanoparticle composition encapsulating paclitaxel (a fungal extract) from 0.5-50% and where the nanoparticle has a phosphatidylcholine such as DPPC from 5-35%, and lipid components of cholesterol and medium chain triglycerides from 2-15% or 25-75% and to balance the remainder of the composition with water. Lipid nanoparticles encapsulating agents such as paclitaxel and having lipids such as cholesterol and DPPC are known from Zhou. It is further known from Zhou that medium chain triglycerides are suitable for the composition. Zhou does not indicate amounts for the components, however, it is known from Kaufman that phospholipids from 5-35% and lipids components such as medium chain triglycerides and cholesterol from 2-15% or 25-75% and a balance of water are suitable for nanoparticle formation. Thus, it would have been obvious to one of ordinary skill to use these lipid components in these amounts for the nanoparticles of Zhou as they are known to be suitable for such compositions and one of ordinary skill would see these as reasonable amounts as Zhou does not teach the amount for each component. One would have a reasonable expectation of success as Zhou and Kaufman both teach lipid nanoparticle formulations and they may be used for similar treatments of cancer and for similar delivery means such as nasal and oral delivery.
Regarding claims 3, 5, 7, 10, 12, 14, 15 and 37, the limitations of these claims are functional properties related to the lipid-based particle composition. The examiner notes that products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Further, "The fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious." Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). The lipid-based particles of the instant claims with the nanoparticle components and their amounts are obvious from the prior art and the particles would necessarily have the same properties as recited in the instant claims.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Zhou et al. (WO 2018237109, published 27 Dec 2018) in view of Kaufman et al. (US 2017/0000744, published 05 Jan 2017, listed in IDS filed 09 May 2023) as evidenced by Velez et al. (Microbiol. 13:956855) as applied to claims 1-5, 7, 10-16, 31 and 37 above and further in view of Danei et al. (Pharmaceutics 2018, 10, 57).
The teachings of Zhou and Kaufman are described supra.
Zhou and Kaufman do not teach the polydispersity of the nanoparticles. This deficiency is made up for in the teachings of Danei.
Danei teaches the impact of polydispersity index on clinical applications of lipid nanocarrier system (title). Danei teaches that the safety and efficacy of therapeutic compounds are limited by inadequate drug delivery to target tissue or undesired side effects (page 7 bottom) and that these concerns can be addressed by encapsulating the drug inside lipid nanocarriers with defined and predictable characteristics (page 8 top). Desai teaches that the tendency of lipid nanocarriers to accumulate in target tissue depends on their physicochemical characteristics such as particle size distribution and that successful formulation of safe, stable and efficient nanocarriers requires the preparation of homogenous populations of nanocarriers of a certain size (page 8 top). Danei teaches that in drug delivery application using lipid-based carriers such as liposomes and nanoliposome formulations that a polydispersity index of 0.3 and below is considered to be acceptable and indicates a homogenous population of phospholipid vesicles (page 8 last paragraph).
Therefore, 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 have formed the lipid particle composition of Zhou and Kaufman with a polydispersity index of less than 0.3. It is known from Desai that a homogenous population of particle sizes is desirable for the formation of safe, stable and efficient nanocarriers and that a polydispersity index of 0.3 and below is considered acceptable and homogenous for nanoliposome formulations. Thus, it would have been obvious to form the nanoparticles with a polydispersity of 0.3 and below as this is considered to be homogenous for lipid nanoparticles and would be desirable for increased safety, stability and efficiency.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Zhou et al. (WO 2018237109, published 27 Dec 2018) in view of Kaufman et al. (US 2017/0000744, published 05 Jan 2017) as evidenced by Velez et al. (Microbiol. 13:956855) as applied to claims 1-5, 7, 10-16, 31 and 37 above and further in view of Geldhof et al. (WO 2017/223135, published 28 Dec 2017).
The teachings of Zhou and Kaufman are described supra.
Zhou and Kaufman do not teach citric acid (the elected species) as the preservative. This deficiency is made up for in the teachings of Geldhof.
Geldhof teaches methods and apparatus for producing lipid nanoparticles (page 5 line 22). Geldhof teaches that exemplary preservatives for the compositions include citric acid (page 34 lines 8-9).
Therefore, 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 have included citric acid as the preservative in the lipid nanoparticle compositions of Zhou and Kaufman. The inclusion of preservatives in the nanoparticle formulation is known from Kaufman and citric acid is known as an exemplary preservative for lipid nanoparticle formulations as taught by Geldhof. Thus it would be obvious to use citric acid as the preservative as it merely represents using a known prior art element for its known purpose, namely as a preservative in lipid nanoparticle formulations.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references.
The claims are alternatively rejected with separate art below
Claims 1-7, 10-17, 31 and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Sloat et al. (WO 2020/123407, published 18 Jun 2020, filed 11 Dec 2018), in view of Zhou et al. (WO 2018237109, published 27 Dec 2018) in view of as evidenced by Velez et al. (Microbiol. 13:956855).
The applied reference has a common joint inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Sloat teaches lipid nanoparticle based composition (e.g. liposome, solid lipid particles, oil in water emulsions) for delivery of hydrophobic therapeutic agents such as plant extracts ([0002]). Sloat teaches inclusion of phosphatidylcholine in greater than about 10% ([0006]), medium chain triglyceride in amount greater than about 10% ([0007]) and cholesterol in an amount greater than about 1% ([0008]). Sloat teaches inclusion of a citric acid preservative ([0011]). Sloat teache water from about 60-80% ([0186]). Sloat teaches the particle composition in a powdered stated with 35-60% phosphatidylcholine, 2.5-10% sterol and 35-50% medium chain triglyceride ([0014]), rendering obvious claim 11. Sloat teaches the powder is configured to be reconstituted ([0200]). Sloat teaches particle sizes of less than or equal to about 10 nm, 50 nm, 100 nm, 250 nm, 500 nm and 1000 nm ([0017]) rendering obvious the particle size of the instant claims. Sloat teaches the size of the nanoparticles increases less than about 15% when reconstituted ([0018]). Sloat teaches a polydispersity less than 0.25 ([0128]), rendering obvious claim 6. Sloat teaches an appreciable amount of the nanoparticle composition does not ssettly from water upon standing (claim 3), rendering obvious instant claim 3. Sloat teaches a change of less than about 20% upon storage for a month (claim 1), rendering obvious claim 5. Sloat teaches the change in polydispersity with 90 day storage less than 100% or 0.1 (claims 8 and 9) rendering obvious claim 7. Sloat teaches change less than 5% in gastric fluid for greater than an hour ([0132]), rendering obvious claim 10, 12 and 37.
Sloat does not teach a fungus extract, a coated biomass. These deficiencies are made up for in the teachings of Zhou.
Zhou teaches supramolecular nanoparticles based on isolated medicinal natural products (MNP) (page 4 lines 15-16). Zhou teaches that the supramolecular particles encapsulate, associate, incorporate or otherwise carry different types of drugs (page 21 lines 26-29). Zhou teaches nanoparticles with similar components to those of Sloat, such as cholesterol (page 30 lines 1-5) phosphatidylcholines (page 38 lines 9-14). Zhou teaches the drug is selected based on the disease or disorder to be treated or prevented (page 53 lines 4-5) including anti-cancer agents such as paclitaxel (page 54 lines 14-21). As evidenced by Velez, paclitaxel is produced by fungi (page 01) and is thus a fungal extract. Zhou teaches that the therapeutic agent is between about 0.5 and about 50% by weight (page 95 claim 17). Zhou further teaches the inclusion of celluloses in the dosage form (page 65 lines 20-25).
Therefore, 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 have paclitaxel (a fungal extract) from 0.5-50% as the active component in the nanoparticles of Sloat. Nanoparticle compositions are additionally taught by Zhou and have similar compnents of cholesterol and phosphatidylcholines and it is known that they may carry active agents such as paclitaxel. Sloat teaches the nanoparticles may be used with various therapeutic agents and it thus would have been obvious to one of ordinary skill that the active may be substituted. Paclitaxel is an obvious agent as it is known for use in nanoparticles as taught by Zhou. It is further obvious to include cellulose as it is a known suitable component for nanoparticle compositions and the inclusion of cellulose renders obvious a coated biomass.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references.
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 1-7, 10-17, 31 and 37 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 11,260,033 in view of Zhou et al. (WO 2018237109, published 27 Dec 2018) as evidenced by Velez et al. (Microbiol. 13:956855), Geldhof et al. (WO 2017/223135, published 28 Dec 2017) and Danei et al. (Pharmaceutics 2018, 10, 57).
Claim 1 of the ‘033 patent recites
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Claims 2-8 recites functional properties that render obvious the functional limitations of the instant claims. Claim 11 recites cholesterol.
The ‘033 patent does not recite the inclusion of a fungus extract, the form of a powder, a polydispersity less than 0.25, or a citric acid preservative, or a coated biomass. These deficiencies are made up for in the teachings of Zhou, Geldhof, and Danei.
The teachings of Zhou, Geldhof and Danei are described supra.
Therefore, 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 have included a components such as paclitaxel (a fungal extract component) from 0.5-50% and to form the composition as a powder. Nanoparticles with similar components such as cholesterol and phosphatidylcholine components are known from Zhou and they are known to be useful for a variety of active agents such as paclitaxel. It would be obvious to one of ordinary skill to use the nanoparticle of the ‘033 patent with different actives such as paclitaxel as nanoparticles are known to carry different active components, as taught by Zhou. It is further known from Zhou that nanoparticles may be formed as powders and reconstitutable, rendering obvious the dry powder form of claims 11. Removal of the water from the composition would increase the percentages of the remaining components, meeting the amounts as in claim 11. The inclusion of cellulose is suitable for nanoparticle compositions, rendering obvious the biomass as in claim 31. The inclusion of preservatives is known form Zhou and citric acid is a known preservative for nanoparticle compositions, as taught by Geldhof rendering obvious the inclusion of citric acid. Having a polydispersity less than 0.3 is obvious from the teachings of Danei as a homogenous population of particle sizes is desirable for the formation of safe, stable and efficient nanocarriers and that a polydispersity index of 0.3 and below is considered acceptable and homogenous for nanoliposome formulations.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references.
Claims 1-7, 10-17, 31 and 37 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 8, 10, 12-16, 18, 22, 23, 25, and 27 of copending Application No. 18/001,089 in view of Zhou et al. (WO 2018237109, published 27 Dec 2018) as evidenced by Velez et al. (Microbiol. 13:956855), Geldhof et al. (WO 2017/223135, published 28 Dec 2017) and Danei et al. (Pharmaceutics 2018, 10, 57).
Claim 1 of the ‘089 application recites a lipid-based particle composition comprising therapeutic agents 1-20%, phosphatidyl choline 2.5-15%, sterol 0.5-5% and medium chain triglyceride 2.5-15%, water 60-95% and a particle size of 20-500 nm. Claims 2 recites liposomes and emulsions. Clam 4 recites forming a powder to be reconstituted. Claim 13 recites the phophatidylcholine from 35-60%, the sterol from 2.5-10% and the triglyceride from 35-50% in the powder. The claims recite function properties that render obvious the functional limitations of the instant claims.
The ‘089 application does not recite the inclusion of a fungus extract, a polydispersity less than 0.25, or a citric acid preservative, or a coated biomass. These deficiencies are made up for in the teachings of Zhou, Geldhof, and Danei.
The teachings of Zhou, Geldhof and Danei are described supra.
Therefore, 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 have included a components such as paclitaxel (a fungal extract component) from 0.5-50% and to form the composition as a powder. Nanoparticles with similar components such as cholesterol and phosphatidylcholine components are known from Zhou and they are known to be useful for a variety of active agents such as paclitaxel. It would be obvious to one of ordinary skill to use the nanoparticle of the ‘089 application with different actives such as paclitaxel as nanoparticles are known to carry different active components, as taught by Zhou. The inclusion of cellulose is suitable for nanoparticle compositions, rendering obvious the biomass as in claim 31. The inclusion of preservatives is known form Zhou and citric acid is a known preservative for nanoparticle compositions, as taught by Geldhof rendering obvious the inclusion of citric acid. Having a polydispersity less than 0.3 is obvious from the teachings of Danei as a homogenous population of particle sizes is desirable for the formation of safe, stable and efficient nanocarriers and that a polydispersity index of 0.3 and below is considered acceptable and homogenous for nanoliposome formulations.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references.
This is a provisional nonstatutory double patenting rejection.
Claims 1-7, 10-17, 31 and 37 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 9, 13, 14, 16, 18, and 27-30 of copending Application No. 18/554,261 in view of Zhou et al. (WO 2018237109, published 27 Dec 2018) as evidenced by Velez et al. (Microbiol. 13:956855), Kaufman et al. (US 2017/0000744, published 05 Jan 2017), Geldhof et al. (WO 2017/223135, published 28 Dec 2017) and Danei et al. (Pharmaceutics 2018, 10, 57).
Claim 1 of the ‘261 application recites a nanoparticle composition comprising at least one nanoparticle, an active agent 1-50%, lipid 1-50% and water 50-97.5%. Claim 4 recites the active agent ins a mushroom extract, rendering obvious the fungus extract of the instant claims. Claim 9 recites the lipid is a phosphatidylcholine. Claim 18 recites a sterol. Claim 29 recites a solid lipid particle.
The ‘261 application does not recite the amount of sterol, medium chain triglyceride, powder form, a polydispersity less than 0.25, or a citric acid preservative, or a coated biomass. These deficiencies are made up for in the teachings of Zhou, Geldhof, and Danei.
The teachings of Zhou, Kaufman, Geldhof and Danei are described supra.
Therefore, 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 have included a cholesterol from 2-15% or 25-75%, have the lipid as medium chain triglyceride and to form the composition as a powder. Nanoparticles with similar components such as lipids and phosphatidylcholine components are known from Zhou and Kaufman and suitable amounts for lipids such as cholesterol and medium chain triglycerides are suitable component for nanoparticles, as taught by Kaufman. The inclusion of cellulose is suitable for nanoparticle compositions, rendering obvious the biomass as in claim 31. Rendering the form as a powder is obvious from Zhou as it is known to be a suitable form for nanoparticles. The inclusion of preservatives is known form Zhou and citric acid is a known preservative for nanoparticle compositions, as taught by Geldhof rendering obvious the inclusion of citric acid. Having a polydispersity less than 0.3 is obvious from the teachings of Danei as a homogenous population of particle sizes is desirable for the formation of safe, stable and efficient nanocarriers and that a polydispersity index of 0.3 and below is considered acceptable and homogenous for nanoliposome formulations. The functional limitations of the instant claims are understood to necessarily be present in the nanoparticle composition rendered obvious as the same composition would necessarily have the same properties.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references.
This is a provisional nonstatutory double patenting rejection.
Claims 1-7, 10-17, 31 and 37 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 and 18-20 of copending Application No. 18/767,811 in view of Zhou et al. (WO 2018237109, published 27 Dec 2018) as evidenced by Velez et al. (Microbiol. 13:956855), Kaufman et al. (US 2017/0000744, published 05 Jan 2017), Geldhof et al. (WO 2017/223135, published 28 Dec 2017) and Danei et al. (Pharmaceutics 2018, 10, 57).
Claim 1 of the ‘811 application recites a nanoparticle composition comprising 60-93.799% water, 0.001-20% active agent, 5-20% phospholipid, 1-15% triglyceride, 0.2-2% sterol. Claim 4 recites a medium chain triglyceride. Claim 6 recites emulsions and claim 7 a preservative.
The ‘811 application does not recite the inclusion of a fungus extract, cholesterol as the sterol, a powder form, a polydispersity less than 0.25, or a citric acid preservative or a coated biomass. These deficiencies are made up for in the teachings of Zhou, Geldhof, and Danei.
The teachings of Zhou, Geldhof and Danei are described supra.
Therefore, 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 have included a components such as paclitaxel (a fungal extract component) from 0.5-50% and to form the composition as a powder and to have cholesterol as the sterol. Nanoparticles with similar components such as cholesterol and phosphatidylcholine components are known from Zhou and they are known to be useful for a variety of active agents such as paclitaxel. It would be obvious to one of ordinary skill to use the nanoparticle of the ‘811 application with different actives such as paclitaxel as nanoparticles are known to carry different active components and to have cholesterol as it is a known nanoparticle sterol, as taught by Zhou. The inclusion of cellulose is suitable for nanoparticle compositions, rendering obvious the biomass as in claim 31. The inclusion of preservatives is known form Zhou and citric acid is a known preservative for nanoparticle compositions, as taught by Geldhof rendering obvious the inclusion of citric acid. Having a polydispersity less than 0.3 is obvious from the teachings of Danei as a homogenous population of particle sizes is desirable for the formation of safe, stable and efficient nanocarriers and that a polydispersity index of 0.3 and below is considered acceptable and homogenous for nanoliposome formulations. The functional limitations of the instant claims are understood to necessarily be present in the nanoparticle composition rendered obvious as the same composition would necessarily have the same properties.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references.
This is a provisional nonstatutory double patenting rejection.
Claims 1-7, 10-17, 31 and 37 directed to an invention not patentably distinct from claims 1-16 and 18-20 of commonly assigned Application No. 18/767,811. Specifically, see above.
Claims 1-7, 10-17, 31 and 37 directed to an invention not patentably distinct from claims 1-13 of commonly assigned U.S. Patent No. 11,260,033 . Specifically, see above.
The U.S. Patent and Trademark Office may not institute a derivation proceeding in the absence of a timely filed petition. The USPTO normally will not institute a derivation proceeding between applications or a patent and an application having common ownership (see 37 CFR 42.411). Commonly assigned Application No. 18/767,811 and U.S. Patent No. 11,260,033 , discussed above, may form the basis for a rejection of the noted claims under 35 U.S.C. 102 or 103 if the commonly assigned case qualifies as prior art under 35 U.S.C. 102(a)(2) and the patentably indistinct inventions were not commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention.
In order for the examiner to resolve this issue the applicant or patent owner can provide a statement under 35 U.S.C. 102(b)(2)(C) and 37 CFR 1.104(c)(4)(i) to the effect that the subject matter and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person. Alternatively, the applicant or patent owner can provide a statement under 35 U.S.C. 102(c) and 37 CFR 1.104(c)(4)(ii) to the effect that the subject matter was developed and the claimed invention was made by or on behalf of one or more parties to a joint research agreement that was in effect on or before the effective filing date of the claimed invention, and the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; the application must also be amended to disclose the names of the parties to the joint research agreement.
A showing that the inventions were commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention will preclude a rejection under 35 U.S.C. 102 or 103 based upon the commonly assigned case. Alternatively, applicant may take action to amend or cancel claims such that the applications, or the patent and the application, no longer contain claims directed to patentably indistinct inventions.
Conclusion
No claim is allowed.
Correspondence
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/E.C.M./Examiner, Art Unit 1619
/ANNA R FALKOWITZ/Primary Examiner, Art Unit 1600