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
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. KR10-2020-0146144, 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. The prior filed application fails to disclose several of the claimed features such as “a corrugated wall having an upper end … in a contracted state” as recited in claim 5, “a second partition wall layer … inside the second partition wall layer” as recited in claim 6, “support parts”, “connection parts” as recited in claim 7, “a support plate” as recited in claims 10 and 13 and “a membrane in which a plurality of storage spaces partitioned by partition walls” as recited in claim 14. Accordingly, the application is not entitled to the benefit of the prior-filed application.
Specification
The disclosure is objected to because of the following informalities:
The reference character “200” has been used to refer to “the material accommodation unit” on page 14, line 19 and “the material accommodation part” on page 14, lines 17-18.
The reference character “300” has been used to refer to “the protective cap” on page 14, line 23 and “microstructure” on page 14, line 24.
The reference characters “100” on page 16, line 8, “110” on page 16, line 4 and “120” on page 25, line 20 are used to refer to “base film”. Please note that examiner has identified one instance and applicant is requested to check the entire specification to ensure no other instances are found.
The reference character “210a” has been used to refer to “bottom surface” on page 24, line 21 and “spaces” on page 18, line 1. Please note that examiner has identified one instance and applicant is requested to check the entire specification to ensure no other instances are found.
Appropriate correction is required.
Claim Objections
Claims 3, 4, 8, 9, 12-14 are objected to because of the following informalities:
Claim 3 recites the limitation “the center” in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 3 recites the limitation “the bottom surface” in line 2. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 4, line 3, the recitation “loacated” appears to be amended to recite “located” to correct the spelling error.
Regarding claim 8, line 2, the recitation “it” should be replaced with the referenced feature being referred in order to clearly identify the referenced feature.
Claim 8 recite the limitation “the lower end” in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 9 recites the limitation “the lower end” in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 12 recite the limitation “the bottom surface” in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 13 recite the limitation “the bottom surface” in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 14 recite the limitation “the opening” in line 3. There is insufficient antecedent basis for this limitation in the claim.
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 2, 3 and 14 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.
Regarding claim 2, line 1, the recitation “one surface” renders the claim indefinite because the claim is unclear if “one surface” refers to “one surface” recited in claim 1, line 2 or additional. For examination purposes, examiner construes that “one surface” in claim 2 refers to “one surface” recited in claim 1. Claim 2 appears to overcome the rejection under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph if claim 2 is amended to recite “the one surface” instead of “one surface”.
Regarding claim 3, lines 2-3, the recitation “one surface” renders the claim indefinite because the claim is unclear if “one surface” refers to “one surface” recited in claim 1, line 2 or additional. For examination purposes, examiner construes that “one surface” in claim 3 refers to “one surface” recited in claim 1. Claim 3 appears to overcome the rejection under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph if claim 2 is amended to recite “the one surface” instead of “one surface”.
Regarding claim 14, line 4, the recitation “an opening” renders the claim indefinite because the claim is unclear if “an opening” refers to “the opening” recited in claim 14, line 3 or additional. For examination purposes, examiner construes that “an opening” in line 4 refers to “the opening” recited in claim 14, line 3. Claim 14 appears to overcome the rejection under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph if claim 14 is amended to recite “the opening” instead of “an opening”
Regarding claim 14, line 8, the recitation of different materials” renders the claim indefinite because the claim is unclear if “different materials” are part of “second material” recited in claim 1, line 5 or additional. For examination purposes, examiner construes that “different materials” are part of “second material”.
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.
Claims 1-3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jung et al. (KR 20180056411 A, Examiner will refer to US 2020/0016388 A1 for English translation of the specification).
Regarding claim 1, Jung teaches a multi-material delivery microsystem (figures 1, 3-5) comprising:
a microstructure (figures 1, 3-5 excluding elements 200, 300) in which microneedles 200 are formed on one surface of a base film 100, and which is made of a first material (paragraph 0044, “solid-phase formulation”); and
a material accommodation part (part of element 100 occupied by element 300) which is located in one region of the microstructure and has an accommodation space (space that occupies/holds element 300) accommodating a second material 300 (paragraph 0044, “liquid-phase formulation”) different from the first material.
Regarding claim 2, Jung teaches wherein the base film 100 has one surface (surface of element 100 supporting elements 200 and 300) including: a central area (see “CA” in figure 5(c) below); and a peripheral area (see “P” in figure 5(c) below) which surrounds the central area and in which the microneedles are formed 200, and the material accommodation part (part of element 100 occupied by element 300) is located in the central area of the base film 100.
PNG
media_image1.png
191
382
media_image1.png
Greyscale
Regarding claim 3, Jung teaches wherein the accommodating space (space that occupies/holds element 300) is located so that the center of the bottom surface (see figures 3(e) and 3(f) where center of the space occupied by element 300 has a surface lower than the surface where element 200 is present) of the accommodation space is lower than one surface of the base film.
Allowable Subject Matter
Claims 4-13 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim 14 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
The closest prior art of record, Jung et al. (KR 20180056411 A), is silent regarding wherein the material accommodation part further includes a ring-shaped partition wall which surrounds the accommodation space and is located so that an upper end thereof is lower than tips of the microneedles in combination with other claimed limitations of claim 4
Claims 5-13 being dependent on claim 4 is also indicated allowable.
The closest prior art of record, Jung et al. (KR 20180056411 A) is silent regarding a membrane in which a plurality of storage spaces partitioned by partition walls are formed in the material accommodation part, and which is positioned in the opening of the base film; an outflow prevention film blocking an opening formed in the base film between the storage spaces and the membrane; and a punching rod of which a plurality of ends are located in each of the storage spaces, and which can hit the outflow prevention film, wherein different materials are stored in each of the storage spaces, and the respective materials are introduced into the membrane through holes formed in the outflow prevention film by hitting of the punching rod and mixed with each other in combination with other claimed limitations of claim 14.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NILAY J SHAH whose telephone number is (571)272-9689. The examiner can normally be reached Monday-Thursday 8:00 AM-4:30 PM EST.
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, CHELSEA STINSON can be reached at 571-270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/NILAY J SHAH/Primary Examiner, Art Unit 3783