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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Specification
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
Claim Objections
Claims 2-25 are objected to because of the following informalities: The claims should start with “The [[A]] process as claimed in claim 1” . Appropriate correction is required.
Claim 11 is objected to because of the following informalities: “a” should be inserted before “biologically active agent.” Appropriate correction is required.
Claims 29-30 are objected to because of the following informalities: The claims should start with “The [[A]] formulation as claimed in claim 28” . 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.
Claims 10, 22-23, 26, 28-31 and 34-35 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.
Claim 10 recites the limitation "the carrier" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 22 recites the limitation "the separate layers" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 23 recites the limitation "resuspending" in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 1 does not require the suspension of the particles in a solvent.
Claim 23 recites the limitation "separated particles" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 26 recites “a composition obtainable by way of a process as defined in claim 1” the phrase obtainable by renders the claim indefinite because it defines the composition solely by the process used to make it, rather than by structural characteristics. It is unclear what the composition encompasses.
Claims 28-30 and 34-35 are included in the rejection since they depend from claim 26.
Claim 31 recites a process for preparing a formulation, but fails to recite process steps on how the formulation is formed. A process claim must set forth the acts or steps that define how the process is carried out otherwise the scope of the claim is unclear. Since the claim lacks the essential steps that characterize the process, one of ordinary skill in the art cannot determine the metes and bounds of the claimed process. Therefore, the claim fails to distinctly claim the invention.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1, 9-15, 1-22, 24-26, 28-31 and 34-35 is/are rejected under 35 U.S.C. 102(b) as being anticipated by Johansson et al. (GB 2576851).
As to claim 1, Johansson et al. discloses a process for coating particles (diameter of 10 nm – 50 microns (see page 10, lines 23-29) comprising a core and two or more layers encapsulating the core. The process comprises applying an initial layer of coating material to the core, subjecting the cores to agitation to deagglomerate particle aggregates using a sieving step; applying an additional coating and where the sieving step comprises vibrational sieving through the use of a vibration motor (see abstract, page 8, lines 25- page 9, line 7). The process comprises a step of deagglomeration using ultrasonic vibration where a sieve that is integrated within the reactor vessel acts as a sonic filter. Johansson et al. states the means for causing vibration of the chamber and sieve can be a solenoid (see page 3, lines 16-30; page 4, lines 17-25 and 29-30; and page 26, lines 19-21 and 30-31). A solenoid requires electrical power to operate.
As to claim 9, the cores comprise biologically active agents (see page 13, lines 4-9).
As to claim 10, the cores can include non-biologically active carries which include sugars and sugar alcohols (see or a pH modifying agent (See page 14, line 3).
As to claims 11-12, the core can consist of a biologically active agent as claimed (see page 13, lines 4-5 and page 14- 15).
As to claim 13, the size of the cores is 10nm -50 microns (see page 10, lines 23-29).
As to claim 14, the number of layers can be 3 to 15 (see page 9,lines 1-6).
As to claim 15, the thickness of the layers can be 5nm to 100 nm (see page 12, lines 1-2).
As to claims 17-21, the coatings can include inorganic materials such as metal/ metalloid oxides (see page 12, lines 15-37). The coatings can include silicon oxide, aluminum oxide, and zinc oxide.
As to claim 22, the layers are formed using atomic layer deposition (see ).
As to claims 24-25, the biologically active agent is an ant-cancer agent such as azacitidine (see page 14, line 8 and page 16, line 29).
As to claim 26, Johansson et al. discloses a composition having particles with a core encapsulated with a coating (see abstract).
As to claim 28, the formulation can include a diluent and carrier (see page 21, liens 6-15).
As to claims 29-30, the formulation can be in liquid, sol or gel form and administered via surgery (see page 23, lines 9-14) through injection.
As to claim 31, Johansson et al. teaches forming formulation comprising a pharmaceutical composition having a carrier (see page 21).
As to claims 34-35, the composition can be used to treat cancer where the core of the particle is formed of the biologically active agent azacitidine and the cancer being treated is myelodysplastic syndrome (see page 14, line 8; page 16, line 29; and page 19 line 18).
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.
Claim(s) 1, 8-9, 11-23, 26 and 28-31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carlsson et al. (US 2016/0081945) in view of Johansson et al. (GB 2576851).
As to claim 1, Carlsson et al. discloses a process for forming a nanoparticle having a solid core encapsulated by an inorganic coating (see abstract). The inorganic coating can comprise multiple layers (see 0037, 0041-0043, and 0047). The particles can have a diameter of 100 nm to 50 microns (see 0070). The process comprises applying a layer over of coating material onto the solid core using a gas phase deposition (see 0091); subjecting the coated particles to agitation to deagglomerate particle aggregates formed using a fluidized bed with a porous plate or screen (see 0110-0112); a further layer is formed of inorganic material (see 0111), and the steps can be repeated to form further layers to achieve the desired thickness (see 0043, 0072, and 0083). Carlsson et al. further states the parts of the reactor can vibrate to keeps the particles moving preventing agglomeration (see 0112).
Carlsson et al. fails to teach electrical power is supplied to a vibration motor coupled to a sieve as required by claim 1.
Johansson et al. discloses an apparatus for coating particles using an ALD method. The process comprises a step of deagglomeration using ultrasonic vibration where a sieve that is integrated within the reactor vessel acts as a sonic filter. Johansson et al. states the means for causing vibration of the chamber and sieve can be a solenoid (see page 3, lines 16-30; page 4, lines 17-25 and 29-30; and page 26, lines 19-21 and 30-31). A solenoid requires electrical power to operate.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the process of Carlsson et al. to include the vibrational sieve to deagglomerate the particles as taught by Johansson et al. One would have been motivated to do so since both are directed to agglomeration of particles during gas-phase coating where Johansson et al. teaches an operable device that can be used in order to provide the vibratory sieving between the coating steps by providing a vibrating motor to a sieve.
As to claim 8, Carlsson et al. discloses removing particles after coating, reintroducing the particles after sieving to form a further layer (see 0050-0054, 0110-0112)
As to claim 9, the cores can comprise a biologically active agent (See 0073 Carlsson et al.).
As to claim 11, the cores consist of a biologically active agent (See 0074 Carlsson et al.).
As to claim 12, the active agent can be one of those as claimed (see 0077-0078 Carlsson et al.).
As to claim 13, the mean diameter is between 1-50 microns (100 nm – 50 microns, see 0070 Carlsson et al.).
As to claim 14, Carlsson et al. states the number of layers can be 3-10 (see claim 6).
As to claim 15, the thickness of the layer can be from 0.5 – 10 nm (see 0080 Carlsson et al.). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)
As to claim 16, Carlsson teaches a maximum thickness of the layers is less than 1 hundredth of the diameter of the core (See Example 6).
As to clam 17, the layers comprise inorganic coating materials (see 0083 Carlsson et al.)
As to claim 18-19, the inorganic material can be met or metalloid materials such as oxides (see 0084-0088 of Carlsson et al.).
As to claims 20-21, the material can be zinc oxide along with aluminum oxide (see 0089 Carlsson et al.).
As to claim 22, the layers are formed using atomic layer deposition (see 0091 Carlsson et al.).
As to claim 23, the separated particles can be suspended in a solvent (see 0136 Carlsson et al.).
As to claim 26, Carlsson et al. discloses providing a composition comprising the nanoparticles having a core and at least two layers encapsulating (see 0138-0140).
As to claim 28, Carlsson et al. discloses a pharmaceutical formulation comprising the particles and a carrier (see 0140).
As to claim 29, Carlsson et al. discloses the pharmaceutical formulation can be injectable or infusible (see 0135).
As to claim 30, the formulation can be in liquid form (see 0132 and 0140).
As to claim 31, Carlsson et al. discloses a process for forming the formulation (See 0132-0140).
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carlsson et al. (US 2016/0081945) in view of Johansson et al. (GB 2576851) as applied to claim 1 above in view of Nakamura et al. (US 6392011).
The teachings of Carlsson et al. and Johansson et al. as applied to claim 1 are as stated above.
Carlsson et al. and Johansson et al. fail to teach the motor is a piezoelectric vibrational motor or an eccentric rotating mass as required by claim 2.
Nakamura et al. discloses the use of an ultrasonic sieve after spray drying particles to prevent aggregates. Nakamura et al. states the sieve is vibrated using a vibrating motor where the motor can be a rotating eccentric weight motor which provides slower movement so that the particles are moved through the sieve (See col. 8, lines 41-61).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the process of Carlsson et al. and Johansson et al. to include the motor as taught by Nakamura et al. One would have been motivated to do so since both are directed to sieving coated particles to prevent aggregation where Nakamura et al. discloses a device that provides vibration and allows for slow movement so the granules can proceed through the sieve.
Claim(s) 3 and 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carlsson et al. (US 2016/0081945) in view of Johansson et al. (GB 2576851) as applied to claim 1 above in view of XU et al. (CN 212041370).
The teachings of Carlsson et al. and Johansson et al. as applied to claim 1 are as stated above.
Carlsson et al. and Johansson et al. fail to teach the motor and sieve are suspended from a mount via suspension means as required by claim 3. The means being a spring or bellows as required by claim 4.
Shows a sieve frame and a vibration motor supported on the frame where the sieve and motor are suspended via springs which reduces vibration of the machine body during operation prolonging the service life.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the process of Carlsson et al. and Johansson et al. to include the suspension as taught by XU et al. One would have been motivated to do so since both are directed to a vibrating sieve where Xu et al. teaches suspending a sieve in order to isolate vibration thereby prolonging the life of the apparatus.
Claim(s) 5-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carlsson et al. (US 2016/0081945) in view of Johansson et al. (GB 2576851) as applied to claim 1 above in view of Nakano et al. (US20030080030).
The teachings of Carlsson et al. and Johansson et al. as applied to claim 1 are as stated above.
Carlsson et al. and Johansson et al. fail to teach the sieving technique comprises controlling the vibration of the sieve, a throughput of at least 1 g/min and the sieve is formed of stainless steel as required by claim 7.
Nakano et al. discloses a vibrating sieve device to prevent agglomeration of particular material. Nakano et al. states the vibrating sieve is typically formed of stainless-steel mesh (see 0062).Nakano et al. states the vibration of the screen is activated by a lead wire which is controlled by a switch. (see 0049). Nakano et al. further teaches the speed of sieving 15kg is at most 1 minute and 8 seconds (see Examples and Table 1).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the process of Carlsson et al. and Johansson et al. to include the vibrating control system, the sieving speed and stainless-steel sieve as taught by Nakano et al. One would have been motivated to do so since both are directed to vibrating sieves to prevent agglomeration and Nakano et al. discloses an operable material for the sieve, sieving speeds and control system to successfully breakup the larger particles.
Conclusion
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/CACHET I. PROCTOR/
Examiner
Art Unit 1715
/CACHET I PROCTOR/ Primary Examiner, Art Unit 1715