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 .
Preliminary Amendment
The preliminary amendments of claims, filed 04/18/2024, has been fully considered.
Status of Claims
Claim 1-14 are pending and under examination.
Information Disclosure Statement
The information disclosure statement (IDS) document(s) submitted on 04/18/2024, 05/02/2025, and 09/01/2026 are compliant with the provisions of 37 CFR 1.97. Accordingly, the IDS document(s) has/have been fully considered by the examiner.
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 13 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 pre-AIA the applicant regards as the invention.
Claim 13 recites “a case body”. Claim 1 further incorporates the limitations of claim 1 which also recites “a case body”. It is unclear if applicant is referring to the case body in claim 1, or if applicant is intending to introduce a second case body.
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.
(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.
Claims 1-2, 5-8, and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Inami et al. (US 2016/0236196 – hereinafter “Inami”).
Regarding claim 1, Inami disclose a container (Inami; figs. 1, & 7-8, #1, [0031, 0061, 0066]) comprising:
a case body that includes a tubular portion in which a fluid is to be sealed (Inami disclose container 1 having a tubular portion 10 contains fluid 162. The container 1 is sealed on the top by pierceable container portion 12 and bendable container portion 11, and is sealed on the bottom by pierceable container portion 15; fig. 7, [0060-0064, 0066]);
a thin film that closes an opening on one end side of the tubular portion, and that is to be punctured so as to form an outflow port for the fluid therein (Inami disclose the bottom of container 1 is sealed by thin film 15 that is punctured by reagent tank projection 165 when plunger 20 is inserted in the reagent tank 160 holding container 1; fig. 8, [0034, 0065-0069]); and
a diaphragm that closes an opening on the other end side of the tubular portion (Inami disclose diaphragm 11 on the other end side of the tubular container portion 10, and expands into the tubular portion 10 when plunger 20 is inserted in the reagent tank 160; figs. 7-8, [0033, 0060-0069]).
Regarding claim 2, Inami disclose the container according to claim 1 above, wherein, on the other end side of the case body, a lid that closes off the diaphragm from an outside space is provided on a side opposite to the thin film with respect to the diaphragm (Inami disclose a lid 12 that closes off the diaphragm 11. The lid 12 is provided on a side opposite of the thin film 15 with respect to the diaphragm 11; fig. 7, [0060-0064]).
Regarding claim 5, Inami disclose the container according to claim 1 above, wherein the case body is formed from a material having a gas barrier property (Inami; [0032]).
Regarding claim 6, Inami disclose the container according to claim 1 above, wherein the thin film is formed from a material having a gas barrier property (Inami; [0034]).
Regarding claim 7, Inami disclose the container according to claim 1 above, wherein the diaphragm is formed from an elastomer material (Inami; [0033]).
Regarding claim 8, Inami disclose the container according to claim 1 above, wherein the container is attached to a microfluidic chip (Inami; figs. 3 & 8, #40, [0045-0046, 0065-0069]) comprising an attachment portion to which the case body is attached (Inami; figs. 3 8, #160, [0045-0046, 0065-0069]), a projecting portion for puncturing the thin film (Inami; fig. 8, #165, [0065-0069]), and a flow passage for the fluid (Inami; fig. 8, #170, [0065-0069]).
Regarding claim 13, Inami disclose a microfluidic device comprising: a microfluidic chip (Inami; figs. 3 & 8, #40, [0045-0046, 0065-0069]) including an attachment portion to which a case body is attached (Inami; figs. 3 8, #160, [0045-0046, 0065-0069]), a projecting portion for puncturing the thin film (Inami; fig. 8, #165, [0065-0069]), and a flow passage for the fluid (Inami; fig. 8, #170, [0065-0069]); and
the container according to claim 1, which is attached to the microfluidic chip by attaching the case body to the attachment portion (The container according to claim 1 has previously been discussed above. Inami disclose the container is inserted into the attachment portion 160; fig. 8, [0065-0069]).
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 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over Inami in view of Montagu et al. (US 2006/0275852 – hereinafter “Montagu”) and Yui (US 2005/0218106 – hereinafter “Yui”).
Regarding claim 3, Inami disclose the container according to claim 2 above, comprising the lid.
Inami does not teach wherein the lid is provided integrally with the case body, a boundary between the lid and the case body is constituted by a thin part, and the lid is removable from the case body by the thin part.
However, Montagu teach the analogous art of a container (Montagu; fig. 6, #50, [0188]) comprising a container body (Montagu; fig. 7, #13, [0188]) and a lid (Montagu; fig. 7, #1, [0188]), wherein the lid is provided integrally with the case body (Montagu; figs. 6-7, [0188]), a boundary between the lid and the case body is constituted by a thin part (Montagu; figs. 7 & 12, “T”, [0228-0232]), and the lid is removable from the case body (Montagu; fig. 12, [0228-0232]).
It would have been obvious to one of ordinary skill in the art before the effective filing to modify the lid and case body of Inami to be integrally formed and comprise a boundary between the lid and body constituting a thin part, as taught by Inami, because Inami teach the boundary between the lid and case body constituting the thin part defines an area for the plunger to engage with the container to release the fluid from the case body (Montagu; fig. 12, [0228-0232]). One of ordinary skill in the art would have expected this modification could have been performed with a reasonable expectation of success since Inami and Montagu both teach releasing fluid from a microfluidic cartridge using a plunger device.
Modified Inami does not teach the lid is removed by tearing the thin part.
However, Yui teach the analogous art of a container (Yui; fig. 2, #12, [0029]) comprising a lid (Yui; fig. 2, #10, [0029]) having a thin part (Yui; fig. 2, #42, [0037]), wherein the lid is removed by tearing the thin part (Yui; [0037]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the lid of modified Inami to be removeable by tearing, as taught by Yui, because Yui teaches removal of the lid by tearing allows flow of liquid from within the container (Yui; [0010]). One of ordinary skill in the art would have expected this modification could have been performed with a reasonable expectation of success since modified Inami and Yui teach a removable lid comprising a thin part that allows access to fluid within a container.
Regarding claim 4, modified Inami teach the container according to claim 3 above, wherein a handle to be pulled to tear the thin part is provided on the lid (The modification of the lid of modified Inami to be removeable by tearing, as taught by Yui, has previously been discussed in claim 3 above. Yui teach a handle 46 to be pulled to tear the thing part provided on the lid 10; fig. 2, [0037, 0039]).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Inami in view of Montagu.
Regarding claim 14, Inami disclose a diaphragm pump (Inami; fig. 8, #21, [0049, 0065-0069]) comprising:
the microfluidic device according to claim 13 (The microfluidic device according to claim 13 has previously been discussed above);
a pressing member configured to press the diaphragm (Inami; fig. 8, #20, [0065-0069]).
Inami does not teach the diaphragm pump comprises an actuator configured to cause the pressing member to perform a reciprocating motion.
However, Inami teach the analogous art of a container (Montagu; fig. 6, #50, [0188]) comprising a container body (Montagu; fig. 7, #13, [0188]), and a diaphragm pump (Montagu; fig. 12, #1B, [0228]), wherein the diaphragm pump comprises an actuator configured to cause the pressing member to perform a reciprocating motion (Montagu; figs. 8E & 12, [0228]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the diaphragm pump of Inami to comprise a motor, as taught by Montagu, because Montagu teach the diaphragm pump comprising a motor for actuation allows the plunger to engage the container by the system control unit in an automated manner (Montagu; [0228]). One of ordinary skill in the art would have expected this modification could have been performed with a reasonable expectation of success since Inami and Montagu both teach releasing fluid from a microfluidic cartridge using a plunger device.
Allowable Subject Matter
Claims 9-12 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.
In addition to the remarks of record, the instant claims define over the prior art because the cited prior art does not teach or suggest the thin film is between a first guide member and a second guide member, each of which has a through hole through which the projection portion is inserted, the first guide member being provided on the diaphragm side and the second guide member being provided on a side opposite to the first guide member with respect to the thin film.
Other References Cited
The prior art of made of record and not relied upon is considered pertinent to Applicant’s disclosure include:
Rupp (US 2011/0086433) disclose a microfluidic chip and container comprising a rigid wall region, an elastic wall region, and an openable wall region.
Hoffmeyer et al. (US 2014/0353157) disclose a container, a microfluidic chip, and a diaphragm pump.
Oppenheimer et al. (US 2015/0190802) disclose a container comprising a fluid delivery system comprising a container and diaphragm pump.
Crivelli et al. (US 2017/0152081) teach a microfluidic device comprising a container and a diaphragm pump.
Asogawa et al. (US 2013/0251603) disclose a container comprising a diaphragm and boundary along the case body constituted by a thin part configured to tear when engaged with a projecting portion.
Citations to art
In the above citations to documents in the art, an effort has been made to specifically cite representative passages, however rejections are in reference to the entirety of each document relied upon. Other passages, not specifically cited, may apply as well.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CURTIS A THOMPSON whose telephone number is (571) 272-0648. The examiner can normally be reached on M-F: 7:00 a.m. - 5:00 p.m..
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E-mail communication Authorization
Per updated USPTO Internet usage policies, Applicant and/or applicant’s representative is encouraged to authorize the USPTO examiner to discuss any subject matter concerning the above application via Internet e-mail communications. See MPEP 502.03. To approve such communications, Applicant must provide written authorization for e-mail communication by submitting the following statement via EFS Web (using PTO/SB/439) or Central Fax (571-273-8300):
Recognizing that Internet communications are not secure, I hereby authorize the USPTO to communicate with the undersigned and practitioners in accordance with 37 CFR 1.33 and 37 CFR 1.34 concerning any subject matter of this application by video conferencing, instant messaging, or electronic mail. I understand that a copy of these communications will be made of record in the application file.
Written authorizations submitted to the Examiner via e-mail are NOT proper. Written authorizations must be submitted via EFS-Web (using PTO/SB/439) or Central Fax (571-273-8300). A paper copy of e-mail correspondence will be placed in the patent application when appropriate. E-mails from the USPTO are for the sole use of the intended recipient, and may contain information subject to the confidentiality requirement set forth in 35 USC § 122. See also MPEP 502.03.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Capozzi can be reached at 571-270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/C.A.T./Examiner, Art Unit 1798
/BENJAMIN R WHATLEY/Primary Examiner, Art Unit 1798
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