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 (CN 2021113623566 – filed 11/17/2021) required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements (IDS) filed on 06/19/2024, 10/15//2024, 05/14/2025, and 01/29/2026 have been certified and made of record.
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 “operating table” and “operating member” (claim 22) 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 Objections
Claim 10 is objected to because of the following informalities: “to allow the external operating member to penetrate to operate the valve” should read “to allow the external operating member to penetrate and to operate the valve”. Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“A storage member” in claim 1 – (The specification teaches the storage member as provided with a groove therein, at least two storage chambers being disposed around the groove)
“A detection device” in claim 22
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
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 22 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Although the specification identifies the detection device as comprising an operating table for accommodating the microfluidic chip and an operating member for operating the valve (para. [0142]), the specification fails to provide the sufficient structure for what an operating table or operating member specifically possesses to perform the function of accommodating the microfluidic chip and operating the valve, respectively.
Claim limitation “detection device” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. As stated above, although the specification identifies the detection device as comprising an operating table for accommodating the microfluidic chip and an operating member for operating the valve (para. [0142]), the specification fails to provide the sufficient structure for what an operating table or operating member specifically possesses to perform the function of accommodating the microfluidic chip and operating the valve, respectively. Therefore, the claim (Claim 22) is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
For examination purposes, the operating table and operating member will be interpreted as any element that accomplishes the function of operating the valve and accommodating the microfluidic chip (ex. A motor).
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claims 4 and 18 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. Specifically, the claim limitation of claim 4, “first storage member inner flow channels are communicated with parts of the storage chambers at the lowest positions”, is unclear regarding where the lowest position starts or begins within the storage chamber. For examination purposes, the limitation “lowest positions” will be interpreted as the bottom of the storage chambers”.
Claim 18 recites the limitation "valve inner flow channel". There is insufficient antecedent basis for this limitation in the claim.
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.
Claims 1 – 6 and 22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dority et al. (US 20210187505 A1) (already referenced in IDS).
Regarding claim 1, Dority et al. teaches a microfluidic chip (fluid control and processing system – element 10), comprising:
a storage member (See annotated FIG. 4 below, housing – element 12) provided with a groove therein (Annotated FIG. 4 below– groove), at least two storage chambers being disposed around the groove (FIG. 1, element 13 – chambers);
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a base (FIG. 8 – element 22), disposed at one end of the storage member away from the groove (See annotated FIG. 9AA – base is disposed away from the groove, with reaction chamber located opposite of the groove), a reaction chamber (FIG. 9AA – element 30) being disposed on the base.
a valve (FIG. 9AA – element 16) disposed in the groove; the valve being configured to operatively communicate any one of the two storage chambers with the reaction chamber (Fig. 9A – 9LL and para. [0043] – “valve 16 is rotatable relative to the housing 12. The housing 12 includes a plurality of chamber ports 25 facing the external port surface 23 of the disk portion 22 of the valve 16 (FIG. 4) to permit fluidic communication between the chambers 13 and the valve 16”).
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Regarding claim 2, Dority et al. teaches the microfluidic chip according to claim 1. Dority et al. further teaches at least two first storage member inner flow channels are disposed in the storage member (chamber ports – element 25), each first storage member inner flow channel is correspondingly communicated with one storage chamber (para. [0043]), a valve inner flow channel communicated with the reaction chamber is disposed in the valve (FIG. 3, See element 26 – gasket contains flow channels) and the valve is configured to operatively communicate the valve inner flow channel with any first storage member inner flow channel (FIG. 4).
Regarding claim 3, Dority et al. teaches the microfluidic chip according to claim 2. Dority et al. further teaches wherein a first end of each first storage member inner flow channel penetrates a bottom wall of the groove (See annotated FIG. 4 in claim 1 rejection), the valve is configured to operatively communicate the valve inner flow channel with the first end of the first storage member inner flow channel (FIG. 4), and a second end of each first storage member inner flow channel is communicated with the storage chamber via one side of the storage chamber adjacent to the base (The housing 12 includes a plurality of chamber ports 25 facing the external port surface 23 of the disk portion 22 of the valve 16 (FIG. 4) to permit fluidic communication between the chambers 13 and the valve 16.” – (para. [0043])).
Regarding claim 4, Dority et al. teaches the microfluidic chip according to claim 3. Dority et al. further teaches wherein the second ends of the first storge member inner flow channels are communicated with parts of the storage chambers at the lowest points (FIG. 9AA – sample chamber 60, FIG. 9BB – waste chamber – wherein the chambers are communicated at their lowest points).
Regarding claim 5, Dority et al. teaches the microfluidic chip according to claim 3. Dority et al. further teaches wherein both a first end and a second end of the valve inner flow channel penetrate one end of the valve adjacent to the bottom wall of the groove (FIG. 4 – structurally, the gasket (element 26) containing the flow channels penetrates the bottom wall of the groove), the first end of the valve inner flow channel is communicated with the reaction chamber (FIG. 9AA), the second end of the valve inner flow channel is operatively communicated with any first storage member inner flow channel (FIG. 4 – structurally, the second end communicated with the storage member inner flow channel present in the groove) the first end of the valve inner flow channel is located in a middle of the valve (FIG. 4 – gasket 26 – flow channels present), and the second end of the valve inner flow channel is close to an outer edge of the valve (FIG. 4 – gasket 26 – flow channels present).
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Regarding claim 6, Dority et al. teaches the microfluidic chip according to claim 1. Dority et al. further teaches a rotor rotatably disposed in the groove (See annotated FIG. 4 above – element 29, toothed periphery) the rotor comprises a valve seat (FIG. 4) and a valve stem (FIG. 4 – element 24, tubular portion), and the valve stem being connected with the valve seat (FIG. 4); and a valve cover connected with a circumferential side wall of the groove and abutting against the valve seat to limit the valve seat between the valve cover and the bottom wall of the groove (FIG. 4), the valve cover being provided with a first through hole, and operating part of the valve stem penetrating the first through hole, and the operating part of the valve stem being configured to be connected with an external operating member (plunger or piston – element 54).
Regarding claim 22, Dority et al. teaches a detection device through a motor “such as a stepper motor is typically coupled to the toothed periphery 29 of the disk portion 22 to rotate the valve 16 relative to the housing 12 for distributing fluid with high precision.” Therefore, the claim is anticipated.
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.
Claims 8-13, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Dority et al. (already referenced) in view of Ge et al. (CN 110856823 B – with provided machine translation) (referenced in IDS).
Regarding claim 8, Dority et al. teaches the microfluidic chip according to claim 1, but fails to teach a sealing film, a top cover disposed at one end of the storage member provided with the groove, and a puncture needle connected to the top cover. Ge et al. teaches a microfluidic chip (para. [0002] of MT), with a connecting module (structurally the top cover) with needles (302, 303, 305) present on the connecting module. Ge et al. further teaches that said needles are used “to insert into the reaction module 2 to break the seal at the first end of the first liquid flow channel 202” (para. [0136]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of filing to use Ge et al.’s teaching of a lid featuring needles in Dority et al.’s microfluidic chip because the connecting module enables the seals to be broken in a reaction module. This method of improving Dority et al.’s microfluidic chip was within the ability of one of ordinary skill in the art based on the teachings of Ge et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Ge et al. and Dority et al. to obtain the invention specified in claim 8.
Regarding claim 9, modified Dority et al. teaches the microfluidic chip according to claim 8. The combination of references of claim 9 would encompass a structure of a microfluidic chip featuring a top comprising a first rib, with the puncture needle is connected to the first rib (Ge et al., FIG. 11). Additionally, Ge et al. teaches the puncture needle as separable from the top cover (FIG. 11). Therefore, the claim is prima facie obvious.
Regarding claim 10, modified Dority et al. teaches the microfluidic chip according to claim 8. Ge et al. further teaches a top cover provided with a second through hole (element 304 – flow channels). The second through hole present in Ge et al.’s device would be structurally capable of being configured to allow the external operating member to penetrate and to operate the valve. Therefore, the claim is prima facie obvious.
Regarding claim 11, modified Dority et al. teaches the microfluidic chip according to claim 8. Ge et al. further teaches that the interior of the needles may be hollow conical structure, as the internal tapered channel of the needle can be used to communicate with channels in a communicating vessel (para. [0141-0142]). Thus, the combination of references of claim 8 would encompass a structure of a microfluidic chip wherein the puncture needle us provided with a needle inner gas channel. Therefore, the claim is prima facie obvious.
Regarding claim 12, modified Dority et al. teaches the microfluidic chip according to claim 11. Ge et al. further teaches a cover sheet disposed in the top cover, and the cover sheet is provided with a fourth through hole, that allows the puncture needle to penetrate (FIG. 11). Furthermore, the combination of references of claim 11 would be structurally capable of being configured to press against the sealing fil under the action of the external force, and continue to press against the sealing film after puncturing the sealing film. Therefore, the claim is prima facie obvious.
Regarding claim 13, Dority et al. teaches the microfluidic chip according to claim 1, but fails to teach a reaction chamber protruding towards one side away from the storage member. Ge et al. teaches a microfluidic chip (para. [0002] of MT), with main reaction chamber (element 201) that protrudes outward from the reaction module (para. [0105] of MT). Ge et al. further teaches energy-conducting structure 211 that protrudes outward from the reaction module 2, which allows vibration energy to be transferred to the main reaction chamber (para. [0105] of MT).
It would have been prima facie obvious to one of ordinary skill in the art at the time of filing to use Ge et al.’s teaching of a protruding reaction chamber in Dority et al.’s microfluidic chip because the protruding structure allows vibration energy to be transferred to the main reaction chamber through an energy conducting structure. This method of improving Dority et al.’s microfluidic chip was within the ability of one of ordinary skill in the art based on the teachings of Ge et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Ge et al. and Dority et al. to obtain the invention specified in claim 13.
Regarding claim 21, modified Dority et al. teaches the microfluidic chip according to claim 8. The combination of references of claim 8 would further encompass a top cover fixedly disposed at one end of the storage member provided with the groove and the base fixedly disposed at one end of the storage member away from the top cover. Therefore, the claim is prima facie obvious.
Claim 15-18 are rejected under 35 U.S.C. 103 as being unpatentable over Dority et al. (already referenced) in view of Park et al. (KR101967236B1 – with provided machine translation) (referenced in 892).
Regarding claim 15, Dority et al. teaches the microfluidic chip according to claim 1. Dority et al. further teaches an amplification member (FIG. 4, reaction vessel – element 18), a side part of the storage member is provided with a slot (FIG. 4 – reaction vessel is inserted into the slot), the slot is located between two adjacent storage chambers (FIG. 9A), the amplification member is connected with the slot in an inserting way (FIG. 9A). Dority et al. fails to teach an amplification chamber present in the amplification member. Park et al. teaches a nucleic acid analyzing apparatus (para. [0001]) including nucleic acid amplification module (FIG. 2 – element 63, structurally the amplification member), where amplification chamber (element 61) is provided in the module (FIG. 2). Park et al. teaches that said amplification chamber performs nucleic acid amplification reaction using the heat applied from a heater unit. (para. [0092]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of filing to use Park et al.’s teaching of an amplification chamber in the amplification member in Dority et al.’s microfluidic chip because adding an amplification chamber enables nucleic acid amplification reactions using a heater unit to be performed. This method of improving Dority et al.’s microfluidic chip was within the ability of one of ordinary skill in the art based on the teachings of Park et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Park et al. and Dority et al. to obtain the invention specified in claim 15.
Regarding claim 16, modified Dority et al. teach the microfluidic chip according to claim 15. Dority et al. further teaches a storage member provided with a second storage member inner flow channel (See annotated FIG. 9KK below – first branch – element 86) penetrates the slot, a second end of second storage member inner flow channel penetrates the groove (Annotated FIG. 9KK), the amplification member is provided with an amplification member inner flow channel, with the amplification member inner flow channel is communicated with the first end of the second storage member inner flow channel (Annotated FIG. 9KK). Furthermore, the combination of references of claim 15 would encompass an amplification chamber connected through the second storage member inner flow channel and the amplification member inner flow channel.
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Regarding claim 17, modified Dority et al. teach the microfluidic chip according to claim 16. Dority et al. further teaches a storage member provided with a third storage member inner flow channel with a first and second end (See annotated FIG. 9KK). Furthermore, the combination of the references of claim 16 would encompass an amplification member provided with an amplification member inner inner gas channel communicated with the first end of the third storage member inner flow channel, and the valve is configured to be operatively communicated with the second end of the third storage member inner flow channel to guide gas in the amplification chamber to one storage chamber through the amplification member inner gas channel and the third storage member inner flow channel.
Regarding claim 18, Dority et al. teaches the microfluidic chip according to claim 15. Dority et al. further teaches fluid displacement region (element 50) present in valve (element 16), which allows piston or plunger (54) to move fluid (gas) to communicate, pump, and produce a suction for drawing fluid into the pumping chamber 50. When the piston 54 moves downward, it decreases the volume of the pumping chamber 50 to drive fluid out of the chamber 50. (para. [0047]). Furthermore, the combination of the references of claim 15 would encompass a valve configured to operatively communicate the valve inner flow channel with the reaction chamber and the amplification chamber, and communicate the valve inner gas channel with the amplification chamber and one storage chamber.
Claims 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Dority et al. (already referenced) in view of Zhao et al. (US 20200164370 A1) (referenced in IDS).
Regarding claim 19, Dority et al. teaches the microfluidic chip according to claim 1, but fails to teach a storage member provided with a storage member inner gas channel. Zhao et al. teaches a nucleic acid extraction apparatus (abstract) featuring a venting element (cylindrical suction column) that connects to the waste storage chamber (FIG. 1A). Zhao et al. further teaches “as the air pressure of the waste storage chamber 202 decreases, the fluid in the reaction chamber 201 enters the waste storage chamber 202, at this time, the fluid can be discharged from the reaction chamber 201 into the waste storage chamber 202 without pressurizing the reaction chamber 201, which is easy to operate and labor-saving” (para. [0115]). Furthermore, Zhao et al. teaches “suction column external end 602 is connected to the air pumping device via a hose (para. [0115]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of filing to use Zhao et al.’s teaching of a storage member inner gas channel in Dority et al.’s microfluidic chip because the inner gas channel enables fluid that can be discharged from the reaction camber into the waste storage chamber without pressurizing the reaction chamber, which is easy to operate and labor saving. This method of improving Dority et al.’s microfluidic chip was within the ability of one of ordinary skill in the art based on the teachings of Zhao et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Zhao et al. and Dority et al. to obtain the invention specified in claim 19.
Regarding claim 20, modified Dority et al. teaches the microfluidic chip according to claim 19. Furthermore, the combination of references of claim 19 would encompass a first end of the storage member inner gas channel penetrates one end of the storage member provided with the groove, and the first end of the storage member inner gas channel is located between two adjacent storage chambers. Therefore, the claim is prima facie obvious.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JULIUS FRANCIS YOH whose telephone number is (571)272-3489. The examiner can normally be reached Monday-Friday: 7:30-5 PM.
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/J.F.Y./Examiner, Art Unit 1799
/William H. Beisner/Primary Examiner, Art Unit 1799
Prosecution Insights