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 .
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 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.
Claims 1, 6 are rejected under 35 U.S.C. 102(a) (1) as being anticipated by Aya et al. (JP2009082207, English translation provided).
Regarding claim 1, Aya discloses that, as illustrated in Figs. 5, 6, a microneedle manufacturing method (page 1, lines 12-15), comprising:
applying a raw material (item 16 in Figs. 5(a), (b) and (c) (polymer solution (page 10, lines 578-579))) containing active pharmaceutical ingredients on one or more concave portions formed in a microneedle mold (i.e., page 6, lines 333-335(i.e., drug is dissolved in the polymer solution)); and
pressurizing the raw material at an internal pressure of a pressurizing chamber to fill microstructures of the one or more concave portions with the raw material while loading the microneedle mold, on which the raw material is applied, into a pressurizing chamber (e.g., as shown in Fig. 6, the solution of the polymer resin is pressurized in the pressure vessel by the pressurized fluid at a pressure of 0.01 MPa to 5 MPa (page 2, lines 95-97)),
wherein the pressurizing of the raw material includes: simultaneously performing injection and discharge of air into and from the pressurizing chamber to create an air flow inside the pressurizing chamber (page 7, lines 377-384) and to simultaneously perform a filling of the one or more concave portions with the raw material (page 7, lines 386-387) and a drying of the raw material (page 2, lines 87-88 (i.e., after pressurizing and filling, drying/solidifying)).
Regarding claim 6, Aya discloses that, as illustrated in Figs. 1, 2, the shape of the microneedles (fine projections) 22 formed on the microneedle sheet is as follows: (1) the tip is sufficiently sharp (page 4, lines 213-214). As illustrated in Fig. 3(c), the concave portions 15 of the mold sheet 13 (page 10, line 578) for forming the microneedles are provided independently of each other.
Claim 7 is rejected under 35 U.S.C. 102(a) (1) as being anticipated by Aya et al. (JP2009082207, English translation provided).
Regarding claim 7, Aya discloses that, as illustrated in Figs. 4, 5, 7, a microneedle manufacturing method (page 1, lines 12-15), comprising:
placing a plurality of microneedle molds (item 13 in Fig. 4 (page 10, line 578)) on at least one jig (item 17 in Fig. 4(b) (page 10, line 579));
applying a raw material (item 16 in Figs. 5(a), (b) and (c) (polymer solution (page 10, lines 578-579))) containing active pharmaceutical ingredients on one or more concave portions formed in a microneedle mold (i.e., page 6, lines 333-335(i.e., drug is dissolved in the polymer solution));
fixing the at least one jig to a tray (item 51 in Fig. 7 (page 10, line 581)); and
pressurizing the raw material at an internal pressure of a pressurizing chamber to fill microstructures of the one or more concave portions with the raw material while loading the microneedle mold, on which the raw material is applied, into a pressurizing chamber (e.g., as shown in Fig. 6, the solution of the polymer resin is pressurized in the pressure vessel by the pressurized fluid at a pressure of 0.01 MPa to 5 MPa (page 2, lines 95-97)),
wherein the pressurizing of the raw material includes: simultaneously performing injection and discharge of air into and from the pressurizing chamber to create an air flow inside the pressurizing chamber (page 7, lines 377-384) and to simultaneously perform a filling of the one or more concave portions with the raw material (page 7, lines 386-387) and a drying of the raw material (page 2, lines 87-88 (i.e., after pressurizing and filling, drying/solidifying)).
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 2, 3 are rejected under 35 U.S.C. 103 as being unpatentable over Aya et al. (JP2009082207, English translation provided).
Regarding claims 2, 3, Aya discloses that, as shown in Fig. 6, the solution of the polymer resin is pressurized in the pressure vessel by the pressurized fluid at a pressure of 0.01 MPa to 5 MPa (page 2, lines 95-97) (overlapping the claimed ranges in claim 3). The pressure vessel 30 has an inlet 34 for supplying a fluid from an end of the container and a fluid outlet 35 provided with a cock 36 for returning to atmospheric pressure (or 1.0 bar) (page 7, lines 364-365) (overlapping the claimed ranges in claims 2, 3). The fluid used for pressurization may be a gas or a liquid. When the pressurized fluid is a gas, air is generally used (page 7, lines 377-380).
For one of ordinary skill in the art at the time the invention was filed would have considered the invention to have been obvious because the range taught by Aya et al. overlap the instantly claimed ranges and therefore are considered to establish a prima facie case of obviousness. It would have been obvious to one of ordinary skill in the art to select any portion of the disclosed ranges including the instantly claimed ranges from the ranges disclosed in the prior art reference, MPEP 2144.05.
Claims 4, 5 are rejected under 35 U.S.C. 103 as being unpatentable over Aya et al. (JP2009082207, English translation provided) as applied to claim 1 above, further in view of Chai et al. (US 2021/0001516) and Omachi et al. (US 10,668,260).
Regarding claims 4, 5, Aya discloses the process of manufacturing the mold sheet 13 in Figs. 3(a), (b), and (c). However, Aya does not explicitly disclose the microneedle mold is manufactured by injection molding a thermoplastic resin.
In the same field of endeavor, microneedle array, as illustrated in Figs. 6, 7, 8, 9, 14, Chai discloses that, in order to achieve the object, a production method of a mold having a recessed pedestal pattern comprises: preparing an insert mold, preparing a mold including a first mold provided with a protruding pedestal shape and a second mold, a holding step of holding the insert mold and the mold together, a clamping step of performing clamping with the first mold and the second mold to form a cavity; and an injection step of filling the cavity with a resin ([0009]).
In the same field of endeavor, microneedle patch, Omachi discloses that, as illustrated in Fig. 3, using this matrix 7, a thermoplastic resin 9 is pressed while being heated to form a resin molding die 10 for the microneedle patch 1. Examples of the usable thermoplastic resin include, …, a polyester-based thermoplastic elastomer, …, a polypropylene resin, …, a vinyl chloride resin, … (col. 10, lines 42-50) (related to claim 5).
It would have been obvious to use the method of Aya to have the process of manufacturing the mold sheet for forming a microneedle array as Chai and Omachi teaches that it is known to have the microneedle mold is manufactured by injection molding a thermoplastic resin, such as a polypropylene resin. It has been held that the combination of known technique to improve similar method is likely to be obvious when it does not more than yield predictable results to one of ordinary skill in the art. KSR Int’l Co. v. Teleflex Inc., 82 USPQ2d 1385 (2007) (See MPEP 2143- exemplary rationales).
Claims 8, 9 are rejected under 35 U.S.C. 103 as being unpatentable over Aya et al. (JP2009082207, English translation provided).
Regarding claims 8, 9, Aya discloses that, as shown in Fig. 7, the solution of the polymer resin is pressurized in the pressure vessel by the pressurized fluid at a pressure of 0.01 MPa to 5 MPa (page 2, lines 95-97) (overlapping the claimed ranges in claim 9). The pressure vessel 30 has an inlet 34 for supplying a fluid from an end of the container and a fluid outlet 35 provided with a cock 36 for returning to atmospheric pressure (or 1.0 bar) (page 7, lines 364-365 and lines 405-415) (overlapping the claimed ranges in claims 8, 9). The fluid used for pressurization may be a gas or a liquid. When the pressurized fluid is a gas, air is generally used (page 7, lines 377-380).
For one of ordinary skill in the art at the time the invention was filed would have considered the invention to have been obvious because the range taught by Aya et al. overlap the instantly claimed ranges and therefore are considered to establish a prima facie case of obviousness. It would have been obvious to one of ordinary skill in the art to select any portion of the disclosed ranges including the instantly claimed ranges from the ranges disclosed in the prior art reference, MPEP 2144.05.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHIBIN LIANG whose telephone number is (571)272-8811. The examiner can normally be reached on M-F 8:30 - 4:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alison L Hindenlang can be reached on 571 270 7001. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SHIBIN LIANG/Examiner, Art Unit 1741
/ALISON L HINDENLANG/Supervisory Patent Examiner, Art Unit 1741
Prosecution Insights