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 .
Information Disclosure Statement
The information disclosure statement filed March 26, 2024 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because non-patent literature (NPL) numbers 1 and 2 were not found. NPL 3-10 are listed twice. NPLs 6 (same as 19) and 28 are illegible and no publication dates are listed. NPL 31 had incorrect publication year. NPLs 25 and 33 are also missing publication dates.
It has been placed in the application file, but the information referred to therein has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-9, 11, and 20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement.
The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The rejected claims recite “at least 103 W/kg” for the energy rate of the mixing device. The phrase means the energy rate in mixing the liquid streams are at least, i.e., a minimum of, 1000 W/kg. However the disclosure consistently limits the energy rate applied to “about 103 to about 1010 W/kg” (pre-grant publication US 2020/0016562 of parent application, paras.0069, 0127, claims 117, 181, 182). In other words there is no discussion of the open-ended or unlimited energy rate as recited in the present claims. None of the dependent claims resolves this issue and therefore are also rejected on this ground.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 10, 12, 13, 17, and 18 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being clearly anticipated by Kigoshi (US 20080226704).
Regarding claim 10 and 16, Kigoshi discloses (title; abstract; paras. 0102-0114; Figs. 1, 2; claims 1-11) a process for preparation of layered particles comprising the following steps.
“(Step 1) The core fine particles are dispersed (suspended) in a liquid containing a polar organic solvent, preferably in an aqueous solution containing a polar organic solvent, more preferably in an aqueous solution containing an alcohol such as ethanol.” (Para.0103).
The action of “dispersing” includes mixing the core fine particles in the liquid. The polar organic solvent is a “reactant” as Applicant does not define or limit that claim term to chemically reactive species (see paras.0062, 0064 in pre-grant publication US 2020/0016562 wherein salts that precipitate out of solution are disclosed as “reactants”). Therefore claims 1 and 10, step (a) reads on Kigoshi’s Step 1.
“(Step 2). A coating layer component constituting a lipid membrane (for example, a lipid which will be a lipid membrane and/or a surfactant) is dissolved in a liquid containing a polar organic solvent (preferably in an aqueous solution containing a polar organic solvent which is the same as or different from the aqueous solution containing a polar organic solvent in the step 1, more preferably in the same aqueous solution containing a polar organic solvent).” (Para.0104). This is a second liquid stream comprising a reactant mixed with a second liquid carrier as in claims 1 and 10, step (b). Polar organic solvent would be water-miscible as in claim 12 and ethanol as are the other solvents in claim 13 (paras.0018, 0094; see paras.0103-04).
“(Step 3) The liquid obtained in the step 1 and the liquid obtained in the step 2 are mixed.” (Para,0105).
“(Step 4) Subsequently, the liquid mixture obtained in the step 3 is flowed from one of the inlets of an in-line mixing means of a device for producing coated fine particles, and a liquid which is miscible with the liquid mixture obtained in the step 3 and does not contain a polar organic solvent or contains a polar organic solvent in a ratio lower than that in the liquid mixture obtained in the step 3 (preferably water) is flowed from the remaining one inlet.” (Para.0106; see Fig. 1 and accompanying text at paras. 0092, 0108, 0112-14).
Figure 1 (and para.0108) shows Liquid A and Liquid B with pumps 5 and 6, pumped into in-line mixing means 1, comprising two inlets, i.e., the “multi-port mixing device” of claim 1, limitations (c )-(e). Thus Kigoshi’s Steps 3 and 4 comprise the continuous pumping for the first and second liquid streams in respective ports of the multi-port mixing device in claims 1 and 10, steps (c) and (d).
Kigoshi teaches “the mixing means equipped … inside the device for producing coated fine particles of the present invention or outside the device through a flow path is not particularly limited and examples thereof include a static mixer, a propeller mixer, a rotor/stator mixer, a turbine mixer, a saw blade, a colloid mill, a high pressure homogenizer and the like,…” (para.00113, emphasis added).
Regarding claims 1 and 10, step (e), Kigoshi teaches the end of Step 4 as “[t]he liquids are mixed, and coated fine particles in which the core fine particles is coated with a lipid membrane is obtained in the form of a suspension.” (Para.0106; see Fig. 1). Also, “[b]y mixing the liquid A and the liquid B, core fine particles are coated with a coating layer, to form the liquid C in which the resulting coated fine particles are dispersed.” (Para.0108.)
Regarding claims 17 and 18, Kigoshi teaches encapsulating protein, peptide, etc. (e.g., para.0047).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Kigoshi (US 20080226704) as applied to claims 10, 12, 13, 17, and 18 above, and further in view of Panagiotou (US 8187554).
Kigoshi does not specifically teach “wherein the mixing is performed by the multi-port mixing device at an energy rate per kilogram of the mixture of liquid streams of at least 103 W/kg” as recited in claims 1, 11, and 20, or the preparation methods as recited in claims 2, 3, 9, and 15.
Panagiotou is drawn to systems and methods comprising an intensifier pump and which “utilize microreactor technology to achieve desired mixing and interaction at a micro and/or molecular level between and among feed stream constituents” (abstract). Like Kigoshi, Panagiotou teaches using “conventional mixing equipment, such as a propeller or a rotor/stator mixer… high shear homogenizer” (col. 13 lines 44-45).
Panagiotou notably teaches introducing first and second reactant streams into a microreactor using turbulent energy dissipation rates on the order of 107 W/kg and higher, e.g., 107 W/kg, to facilitate a particle coating process (see Fig. 1, col. 6, lines 19-33, col. 10 lines 5-26,45-56, col. 13 lines 21-26, 52-57, col. 18 lines 17-36).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date to combine the teachings of Kigoshi and Panagiotou and perform the mixing using multi-port mixing device of Kigoshi at “an average energy rate per kilogram of the mixture of liquid streams of at least 103 W/kg” as recited in the instant claims 1, 11, and 20. The skilled person would have been suggested to do so because both are drawn to drug composition processes comprising mixing of fluid streams comprising suspensions, and Panagiotou teaches that energy dissipation rates on the order of 107 W/kg and higher “achieves rapid micro-mixing (time scale 4 µs) and meso-mixing (time scale 20 µs)”. (col.6 lines 31-37).
Regarding claims 2 and 19, Kigoshi states the “core fine particles are dispersed (suspended) in a liquid” (para.0103), and “ it is preferred that almost all or all the core fine particles are dispersed” (para.0093). Therefore the skilled person would have been motivated to use a means of deagglomerating the core fine particles, to achieve “almost all or all” of them being dispersed in the liquid.
Regarding claim 3, Kigoshi does not explicitly recite an effective period of time from about 1 microsecond to about 1 hour. Panagiotou teaches introducing first and second reactant streams into a microreactor for a period of time 4 microseconds to facilitate a particle coating process (see Fig. 1, col. 6, lines 19-33, col. 10 lines 5-26 and 45-56, and col. 13 lines 21-26 and 52-57). It would have been obvious to one of ordinary level of skill in the art before the effective filing date of the invention to modify Kigoshi with the teaching of Panagiotou to introduce first and second reactant streams into a microreactor for a period of time 4 microseconds and form a desired coating layer on core particles.
Regarding claim 4, Kigoshi teaches further processing of the coated file particles such as lyophilization (para.0117).
Regarding claim 5, Kigoshi teaches that one or more reactants in the first liquid stream are acids (paras. 0047, 0085).
Regarding claim 6, Kigoshi teaches that the same liquid is used in the first liquid stream and the second liquid stream (paras. 0092, 0094).
Regarding claims 7 and 8, Kigoshi teaches encapsulating protein, peptide, etc. (e.g., paras.0047, 0099).
Regarding claim 9, Kigoshi teaches disposition of the coating layer as the previously-dissolved coating layer component “reacts” with the solvent in the first stream or Liquid A (pars.0092-93). Kigoshi does not explicitly recite that one or more reactants in the first liquid stream react with one or more reactants in the second liquid stream when the first liquid stream and second liquid stream are mixed in step (e). However Panagiotou teaches introducing first and second reactant streams into a microreactor to facilitate a particle coating process (see Fig. 1, col. 10 lines 5-26 and 45-56, and col. 13 lines 21-26 and 52-57). It would have been obvious to one of ordinary level of skill in the art before the effective filing date of the invention to modify Kigoshi with the teachings of Panagiotou for the purpose of coating core particles with desired reactants.
Regarding claim 14, Kigoshi teaches the “ratio of the core fine particles to be used in the method of producing coated fine particles of the present invention to … the liquid C [mixed stream] is not particularly limited as long as it allows the core fine particles to be coated with the coating layer component, however, it is preferably 1 μg/mL to 1 g/mL, more preferably 0.1 to 500 mg/mL” (para.0100). Approximating the fluid portion of the mixed liquid C having the density of water, the weight range of the core fine particles overlap the ranges in claim 14. One of ordinary skill in the art at the time of the invention would have recognized the core particle concentration as a result-effective variable that affects coated particle formation. For result-effective variables, in the case where claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. MPEP § 2144.05 (citations omitted). Furthermore, optimization within prior art conditions or through routine experimentation does not support patentability absent comparative evidence of criticality of the claimed range. See MPEP § 2144.05 (II) (citations omitted).
Regarding claim 16, as discussed above Kigoshi teaches dispersing core fine particles in Liquid A. While Kigoshi does not expressly teach a further addition after the dispersing, mere duplication of parts has no patentable significance unless a new and unexpected result is produced. Applicant has not demonstrated any criticality of the use of the repeat introduction of the core fine particles by comparative experimental results. See MPEP § 2144.04 (IV)(B)(citations omitted).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11938456.
Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets are drawn to a process for the preparation of layered particles, the process comprising: (a) forming a first liquid stream, wherein forming the first liquid stream comprises (i) obtaining a first mixture of immiscible fluids that contains one or more core particles inside a first liquid carrier and (ii) introducing one or more reactants into the first mixture, and wherein the first mixture is an emulsion; (b) forming a second liquid stream; (c) pumping the first liquid stream into a first port of a multi-port mixing device; (d) pumping the second liquid stream into a second port of the multi-port mixing device; and (e) mixing the first liquid stream and the second liquid stream by the multi-port mixing device for an effective period of time to form a layer on the one or more core particles. The difference is that the present claims recite multi-port mixing device at an energy rate per kilogram of the mixture of liquid streams of at least 103 W/kg whereas the ‘456 patent’s claims recite “about 103 to about 1010 W/kg”. However the ranges overlap at “about” 103 W/kg. For result-effective variables, in the case where claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. MPEP § 2144.05 (citations omitted). Furthermore, optimization within prior art conditions or through routine experimentation does not support patentability absent comparative evidence of criticality of the claimed range. See MPEP § 2144.05 (II) (citations omitted).
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to H. S. PARK whose telephone number is (571)270-5258. The examiner can normally be reached on weekdays.
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/H. SARAH PARK/Primary Examiner, Art Unit 1614
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