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.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 03/31/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
The information disclosure statement (IDS) submitted on 05/16/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the pressing device of claim 6 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 1-6, 8 and 10-20 are rejected under 35 U.S.C. 102a1 as being anticipated by Choi et al. (US 2018/0272331 A1 – hereafter ‘331).
‘331 discloses a device for preparing and dispensing a biological sample (Abstract) that includes the following limitations for claim 1:
“A reagent re-embedding and sample injecting device”: ‘331 discloses a sample dispensing device (Fig. 10; [0095]) that is being interpreted as the reagent re-embedding and sample injecting device of the instant application.
“a reagent container for sealing and storing a reagent in advance”: ‘331 discloses a reagent container that stores a reagent (upper cap 600; Fig. 10; [0095]).
“a sample injection seat having”: ‘331 discloses a chamber portion (portion 500; Fig. 10; [0095]) that interacts with the reagent container and is being interpreted as the sample injection seat of the instant application.
“a cavity structure, the reagent container being arranged at a top open end of the cavity structure”: ‘’331 discloses a cavity within the chamber portion that includes an inner groove ([0097]; groove 530) and liquid pathways. The upper chamber is connected to the chamber portion at the open top portion of the chamber.
“a bottom outlet end configured to extend into a gap cavity of a digital microfluidic chip”: ‘331 discloses a sampling tip (tip 720; Fig. 10; [0123]) that extends into a gap of a microfluidic chip (Fig. 13).
“a liquid injection column arranged at the bottom of the cavity structure”: ‘331 discloses a discharge line (line 522; Fig. 11; [0102]) that is at the bottom of the column.
“wherein a piercing component is provided at an end of the liquid injection column close to the reagent container and configured for piercing the reagent container to allow the reagent in the reagent container to flow into the gap cavity of the digital microfluidic chip from the bottom outlet end of the sample injection seat.”: ‘331 discloses a protruding blade portion (blade 554; Fig. 11; [0104]) that is at one end of the discharge line and pierces a sealing cover (cover 640; [0104]; Fig. 11) that allows the reagent to flow through the discharge line, through the sample tip and into the gap of the microfluidic chip.
For claim 2, ‘331 discloses a sealing cover (cover 640; Fig. 11; [0104]; ]0121]) that is being interpreted as the thin film of the instant application. Furthermore, the sealing cover is arranged at the bottom of the upper cap and is used to seal the cap while being configured to hold the reagent.
For claim 3, the sealing cover of ‘331 is bonded to the upper cap, i.e. the reagent container, by bonding ([0121]) where this includes a heat packaging treatment. It should be noted that the “and/or” in the claim is being interpreted to mean that only one of the clauses needs to be met by the prior art in order to anticipate or render obvious the instant claim.
For claim 4, ‘331 discloses a holding section (Fig. 11) that supports the upper cap and can hold a fluid ([0114]; [0115]) that includes a ripping portion (portion 550; Fig. 11; [0104]) that includes the blade for piercing the sealing cover. With regards to the sections being molded integrally, Applicant is reminded that process steps in an apparatus are not accorded patentable weight. “The patentability of a product does not depend on its method of production”. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process (In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985)." Furthermore, the processing steps do not structurally define the instant application over the prior art since the claimed processing steps do not impart a distinctive structural characteristic to the final product.
For claim 5, ‘331 discloses that a hole is provide at the bottom of the chamber portion (Fig. 11; [0102]) that allows the reagent to flow through the sample tip (tip 700; Fig. 11) and into the chamber insertion holder (holder 910; Fig. 14; [0100]), i.e the gap cavity of the chip (cartridge 4).
For claim 6, ‘331 discloses that the upper cap of ‘313 is pressed down in order to deliver the reagent to the cartridge and therefore, a pressing device is an inherent feature of the prior art system.
For claim 8, ‘331 discloses a locking portion 514; Fig. 9; [0099]) that is being interpreted as the hook of the instant application.
For claim 10, ‘313 discloses that the upper cap (cap 600; Fig. 9; [0120]) has an inner cavity for holding the reagent (chamber 622) that is surrounded by a spaced apart outer wall (Fig. 9).
For claim 11, ‘313 discloses that the reagent cavity (chamber 622; [0121]) is aligned with the discharge line (line 522; Fig. 10; [0102]) and an inner wall of the upper cap is in a seal fit with an outer wall of the chamber portion (portion 500; Fig. 10) when the upper cap is pressed down onto the chamber portion.
For claim 12, ‘313 discloses a recessed portion at the bottom of the cavity that is fully capable of accommodating the blade (Fig. 10).
For claim 13, ‘313 discloses that the upper container includes a protrusion (protrusion 552; Fig. 10; [014]) that is being interpreted as a hook and is used to fix the top of the chamber portion with the bottom of the upper cap.
For claim 14, ‘313 discloses that the top of the upper cap has a recess that can hold reagent when the blade pierces the sealing cover (Fig. 10; [0113]).
For claim 15, ‘313 discloses that the liquid injection hole extends from the bottom of the chamber portion and through the discharge line and leads to the top of the sample chamber where the hole is next to the blade (Fig. 11).
‘313 discloses the following limitations for claim 16:
“A sample injection method for a reagent pre-embedding and sample injecting device according to claim 11”: ‘313 discloses a method of injecting a reagent into a cartridge using the device of claim 1 ([0160]).
“pressing a reagent container such that a piercing component pierces the reagent container and a reagent in the reagent container flows into a gap cavity of a digital microfluidic chip from a bottom outlet end of a sample injection seat.”: ‘313 discloses the step of pressing the upper container with the pressing device to flow the reagent from the upper container, into the chamber portion and through the sampling portion into the gap of a cartridge ([0160]). This would be done in an automatic manner.
For claim 17, ‘313 discloses using the pressing device to inject the reagent where this is being interpreted as being done in an automatic manner ([0160]; [0161]).
For claim 18, the device of ‘313 is being interpreted as being used in the field of digital microfluidic chips ([0030]; [0089]). See also MPEP §2114.
For claim 19, ‘313 discloses that the cap has reinforcing members on the outside of the cap (Fig. 12). It should be noted that the “and/or” in the claim is being interpreted to mean that only one of the clauses needs to be met by the prior art in order to anticipate or render obvious the instant claim.
For claim 20, ‘313 discloses that the cap has reinforcing members on the outside of the cap (Fig. 12). It should be noted that the “and/or” in the claim is being interpreted to mean that only one of the clauses needs to be met by the prior art in order to anticipate or render obvious the instant claim.
Therefore, ‘313 meets the limitations of claims 1-6, 8 and 10-20.
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.
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 7 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Choi et al. (US 2018/0272331 A1 – hereafter ‘331) in view of Nana et al. (US 2017/0268039 A1 – hereafter ‘039).
‘331 (Choi) does not explicitly disclose the volume of the reagent chamber.
‘039 (Nana) discloses a system that uses vessel caps for reactions vessels (Abstract) that for claim 7 includes have a reaction chamber sized for a volume of 5 microliters to 100 microliters ([0028]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the earliest effective filing date to employ the volume of ‘039 within ‘331 in order to have a cap that can seal the system ([0036]).
For claim 9, ‘331 does not explicitly disclose the material used for the system.
For claim 9, ‘039 discloses that the cap is made from polypropylene ([0033]). Applicant is reminded that process steps in an apparatus are not accorded patentable weight. “The patentability of a product does not depend on its method of production”. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process (In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985)." Furthermore, the processing steps do not structurally define the instant application over the prior art since the claimed processing steps do not impart a distinctive structural characteristic to the final product.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the earliest effective filing date to employ the polypropylene of ‘039 within ‘339 in order to use a material with low cytotoxicity to biological samples. The suggestion for doing so at the time would have been in order to choose a suitable material for the cap and vessel ([0033]). See also MPEP §2144.07.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Dohale et al. (WO 2017/112911 A1) discloses a system for analyzing biological samples.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL L HOBBS whose telephone number is (571)270-3724. The examiner can normally be reached Variable, but generally 8AM-5PM M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Marcheschi can be reached at 571-272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL L HOBBS/Primary Examiner, Art Unit 1799
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