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
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Objections
Claim 4 is objected to because of the following informalities:
Claim 4 is a device claim but written as a process, which is not given weight in a claim to a device. If the claim was re-written to indicate the connection of the elements recited therein so the structure is defined before the flow is described it would read as a device claim.
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 1-13 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.
Claim 1 recites the limitation "a microfluidic channel" in lines 6, 10 -11 to refer to two different channels. In order to clearly define different channels, some distinguishing language must be used, such as “a first microfluidic channel” and “a second microfluidic channel”. Appropriate correction is needed to either change to –the microfluidic channel—in which refers to the microfluidic channel connecting the sample injection chamber and the sample quantitative chamber or change to – a second microfluidic channel—if referring to a new microfluidic channel.
Claim 4 recites the limitation " the corresponding liquid outflow chamber" in line 4. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is needed to change to –a sample blank cavity—.
Claim 4 recites the limitations "microfluidic channel I”, “microfluidic channel II”, “microfluidic channel III”, and “microfluidic channel IV” in lines 3 and 5. This is the first time the channels are labeled. Claim 1 refers to 2 microfluidic channels with no labels. Appropriate correction is to label all microfluidic channels within the device to better distinguish them all or determine another appropriate distinction for all of the microfluidic channels within the device.
Claim 9 recites the limitation " the microfluidic channel between the sample quantitative chamber and the sample overflow chamber" in lines 2 and 3 and “the microfluidic channel between the diluent quantitative chamber and the diluent overflow chamber” in lines 15 and 16. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is needed within claim 9.
Claim 10 recites the limitation “fan-shaped” in line 2. “Fan” shape does not have a defined meaning and is not clear what shape is claimed. Appropriate correction is needed within claim 10.
Claim 11 recites the limitation “the chip body is located at lower layer” in relation to the upper and middle layers. This is the first time layers are introduced into the claims, so it is not clear where the upper and middle layers are in relation to the structure of claim 1.
Claim 13 recites “chip body is used for detection in biochemical items, immune items, nucleic acid molecule items, and blood coagulation items” is indefinite because it merely recites a use without any active, positive steps delimiting how this use is actually practiced. Attempts to claim a process without setting forth any steps involved in the process raises an issue of indefiniteness. For example, a claim which read: "[a] process for using monoclonal antibodies of claim 4 to isolate and purify human fibroblast interferon" was held to be indefinite because it merely recites a use without any active, positive steps delimiting how this use is actually practiced. Ex parte Erlich, 3 USPQ2d 1011 (Bd. Pat. App. & Inter. 1986), see MPEP 2173.05(q).
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 9 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 9 further limits two different microfluidic channels which are not within claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 13 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim does not fall within at least one of the four categories of patent eligible subject matter because it is a “use” clam that does not purport to claim a process, machine, manufacture, or composition of matter. See MPEP 2173.05(q). Claim 13 merely recites a use (e.g. chip body is used for detection in biochemical items, immune items, nucleic acid molecule items, and blood coagulation items) without any active, positive steps delimiting how this use is actually practiced.
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.
Claims 1, 6-9 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Ermantraut et. al. (WO 2009013321 A2) in view of Kang (CN 109999931 A), machine translation.
Regarding claim 1, Ermantraut teaches “a multifunctional microfluidic detection chip,” (Page 144 line 22, Referring to FIG. 3, micro fluidic cartridge 300); “wherein the chip comprises a chip body,” (Page 144 line 27, Fig. 3, flexible substrate 303) “on which a sample injection chamber” (Page 143 line 17, a first liquid inlet 310); “a sample quantitative chamber” (Page 143 line 17-18, First reagent chamber 314),
Ermantraut does not teach “a sample overflow chamber,”. However Ermantraut does teach a window portion that detects liquid overflows within (Pages 160-161 line 26- 2) so there is a need for a overflow chamber.
Kang teaches a detection micro-fluidic chip and that the sample used in the detection may be blood. Kang also teaches “a sample overflow chamber,” (Abstract, a sample overflow groove.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ermantraut to incorporate the teachings of Kang to include a sample overflow chamber in the microfluidic detection chip. Doing so would allow for a more controlled fluid flow within the chip and minimizes excess liquid in other areas of the chip.
Ermantraut further teaches “a diluent storage chamber” (Page 143 lines 18-19, a second liquid inlet 318); “a diluent quantitative chamber” (Page 143 line 19, second reagent chamber 320);
Ermantraut does not teach “a diluent overflow chamber,”.
Kang teaches “a diluent overflow chamber,” (Page 9, diluting and the liquid overflow groove).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ermantraut to incorporate the teachings of Kang to include a diluent overflow chamber in the microfluidic chip. Doing so allows for a more controlled fluid flow of the diluent within the chip and minimizes excess liquid (diluent) in other areas of the chip.
Ermantraut further teaches “a quantitative mixing chamber,” (Page 143 line 20, Junction 307); “a reaction chamber” (Page 143 line 21, an amplification-labelling reagent chamber 328 and waste chamber 334) “and vent holes are disposed;” (Page 118 line 11-12, A reaction chamber of a device used in the method may further comprise one or more openings).
The recitation “the sample injection chamber is used for injecting a reaction sample to be detected,” is intended use of the chip. Therefore, the prior art teaches to all of the positively claimed limitations and can function as intended to.
Ermantraut further teaches “and is connected to the sample quantitative chamber through a microfluidic channel,” (Page 143 line 17, channel 312);
The recitation “the reaction sample enters the sample quantitative chamber from the sample injection chamber, and the excess reaction sample enters the sample overflow chamber;” is intended use of the chip. Therefore, the prior art teaches to all of the positively claimed limitations and can function as intended to.
Ermantraut further teaches “the diluent storage chamber is connected to the diluent quantitative chamber through a microfluidic channel,” (Page 143 line 19, channel 319);
The recitation “a diluent enters the diluent quantitative chamber from the diluent storage chamber, and the excess diluent enters the diluent overflow chamber;” is intended use of the chip. Therefore, the prior art teaches to all of the positively claimed limitations and can function as intended to.
Ermantraut further teaches “the reaction chamber includes one or more reaction cavities and a sample blank cavity;” (Page 143 lines 21-23, an amplification-labelling reagent chamber 328 and waste chamber 334).
The recitation “after the reaction sample in the sample quantitative chamber is mixed with the diluent in the diluent quantitative chamber uniformly in the quantitative mixing chamber, mixed liquid enters the reaction cavities through microfluidic channels and reacts with a reaction reagent therein for detection, and the mixed liquid enters the sample blank cavity at the same time as a sample blank for detection;” is intended use of the chip. Therefore, the prior art teaches to all of the positively claimed limitations and can function as intended to.
The recitation “the-dimensional size of the reaction cavities is the same as that of the sample blank cavity, channel of the sample blank cavity is wider than those of the reaction cavities;” is not explicitly taught however the specification does not indicate that the three-dimensional sizes or the width of the channels and cavities are critical. Without some showing of unexpected results, or statement of criticality, it would have been obvious to one of ordinary skill in the art to determine, through routine experimentation, an optimum three-dimensional size of the reaction cavities and the sample blank in addition to a optimum width of the channel and the cavity would be selected.
The recitation “the quantitative ratio of the reaction sample to the diluent in the quantitative mixing chamber is less than 1:30.” is intended use of the chip. Therefore, the prior art teaches to all of the positively claimed limitations and can function as intended to.
Regarding claim 6, modified Ermantraut teaches all of claim 1 as above. The recitation “wherein the quantitative ratio of the reaction sample to the diluent in the quantitative mixing chamber is 1:50.” is intended use of the chip. Therefore, the prior art teaches to all of the positively claimed limitations and can function as intended to.
Regarding claim 7, modified Ermantraut teaches all of claim 1 as above. The recitation “ wherein the reaction reagent is lyophilized beads prepared by lyophilization.” is intended use of the chip. Therefore, the prior art teaches to all of the positively claimed limitations and can function as intended to. However further taught (Page 144 lines 1-2, Typically, reagent chambers 306, 314, 320, 328 include lyophilized reagents (for instance, as pellets) used to perform steps as described for method 100.)
Regarding claim 8, modified Ermantraut teaches all of claim 1 above. The recitation “wherein the lyophilized beads have a radius ranging from 0.5 mm to 1 mm.” is intended use of the chip. Therefore, the prior art teaches to all of the positively claimed limitations and can function as intended to.
Regarding claim 9, modified Ermantraut teaches all of claim 1 above but does not teach “wherein the microfluidic channel between the sample quantitative chamber and the sample overflow chamber is provided with a sample vent channel connected to the outside of the chip, and the microfluidic channel between the diluent quantitative chamber and the diluent overflow chamber is provided with a diluent vent channel connected to the outside of the chip.”
Kang teaches “wherein the microfluidic channel (Pages 2, 3, and Fig. 2, formed by the micro-channel network, it can control fluid through the whole system. The connection between number 11 and 12. The sample overflow groove is connected with one end of the hole away from the sample.) between the sample quantitative chamber (Pages 2, 3, and Fig. 2, 11, the sample quantitative groove) and the sample overflow chamber (Pages 2, 3, and Fig. 2, 12, the sample overflow groove) is provided with a sample vent channel (Pages 2, 3, and Fig. 2, 13, first vent hole, a first vent hole communicating with the inside of said first vent hole through the substrate is provided) connected to the outside of the chip, and the microfluidic channel (Pages 2, 3, and Fig. 2, formed by the micro-channel network, it can control fluid through the whole system. The connection between number 21 and 22. Overflow slot is connected with the dilute solution,) between the diluent quantitative chamber (Pages 2, 3, and Fig. 2, 21, dilute solution quantitative groove) and the diluent overflow chamber (Pages 2, 3, and Fig. 2, 22, diluting the liquid overflow groove) is provided with a diluent vent channel (Pages 2, 3, and Fig. 2, 23, first vent hole, is provided with a second vent hole communicating with the inside of the second vent hole through the base plate.) connected to the outside of the chip.” Therefore the vent holes go through the base plate and also the substrate which provides for a vent to the outside of the chip.
Provided the claims required microfluidic channels between the sample quantitative chamber and the sample overflow chamber in addition to between the diluent quantitative chamber and the diluent overflow chamber Ermantraut nor Kang teach such arrangement. However, it would have been clearly within the ordinary skills of an artisan before the effective filing date of the claimed invention to have modified the invention of Ermantraut in view of Kang by having two microfluidic channels connecting the chambers, since Kang teaches they are connected within the Figures and teachings of the fluid movement in addition to teaching that the chip is a micro-channel network. It would have been a matter of an obvious engineering choice, to then select a microfluidic channel to connect the two as is a micro-channel network and having the two connected allows for faster fluid transfer in addition to increase fluid flow.
Regarding claim 13, modified Ermantraut teaches all of claim 1 above. The recitation “wherein the chip body is used for detection in biochemical items, immune items, nucleic acid molecule items, and blood coagulation items.” is intended use of the apparatus. Therefore, the prior art teaches to all of the positively claimed limitations and can function as intended to. In addition, Ermantraut teaches (Page 5 lines 8-10, with such a device, it may be possible to detect nucleic acids associated with an HIV infection in a whole blood sample of a patient, in a qualitative or in a quantitative manner.).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Ermantraut et. al. (WO 2009013321 A2) in view of Kang (CN 109999931 A), machine translation as applied to claim 1 above, and further in view of Xu et. al. (CN 110058007 A), machine translation.
Regarding claim 2, modified Ermantraut teaches all of claim 1 as above but does not explicitly teach “wherein the sample quantitative chamber includes a first sample quantitative cavity and a second sample quantitative cavity.”.
Xu teaches a single-channel micro-fluidic chip in addition to “wherein the sample quantitative chamber includes a first sample quantitative cavity and a second sample quantitative cavity.”. (Page 2, quantitative reaction chamber are separated into upper and lower two parts, corresponding to the upper part of the reaction chamber; lower part of the reaction chamber).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ermantraut to incorporate the teachings of Xu wherein the sample quantitative chamber includes a first sample quantitative cavity and a second sample quantitative cavity. Doing so would allow for more than one quantitation to happen at one time in addition to increasing the sensitivity of the chip in its quantitative abilities.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Ermantraut et. al. (WO 2009013321 A2) in view of Kang (CN 109999931 A), machine translation as applied to claim 1 above, and further in view of Ho (US 20040132218 A1).
Regarding claim 3, modified Ermantraut teaches all of claim 1 as above but does not teach “wherein the reaction chamber includes a plurality of equidistantly distributed reaction cavities.”.
Ho teaches A biochip and apparatus is disclosed for performing biological assays in a self-contained microfluidic platform. In addition to “wherein the reaction chamber includes a plurality of equidistantly distributed reaction cavities.”. (Fig. 1 and Para [0018], The sample can be delivered into individual reaction wells directly or via a main sample port 15 for equal distribution. The biochip body structure comprises a plurality of reagent cavities and reaction wells via microchannels.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ermantraut to incorporate the teachings of Ho wherein the reaction chamber includes a plurality of equidistantly distributed reaction cavities. Doing so increases the number of reactions the chip is able to perform in addition to having them placed to ensure each reaction chamber is set up in the same way to ensure uniformity with the chip and reactions.
Claims 4 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Ermantraut et. al. (WO 2009013321 A2) in view of Kang (CN 109999931 A), machine translation as applied to claim 1 above, and further in view of XU et. al. (CN 205176030 U), machine translation.
Regarding claim 4, modified Ermantraut teaches all of claim 1 as above. The recitation “wherein after the reaction sample in the sample quantitative chamber and the diluent in the diluent quantitative chamber enter the quantitative mixing chamber through microfluidic channel I and microfluidic channel II, respectively and are mixed uniformly,” is capability of the apparatus. Ermantraut discloses the positively claimed structural elements of the chip as claimed, such apparatus are said to be fully capable of the recited adaption in as much as recited and required herein. Including the taught channel in which the connection to both chambers is “through microfluidic channel I” (Page 143 line 18, channel 316); “and microfluidic channel II” (Page 143 line 20, channel 322);. Further capability is “the mixed liquid enters the reaction cavities and the sample blank cavity through microfluidic channel III and microfluidic channel IV successively,”. However, Ermantraut does teach “microfluidic channel III” (Page 143 line 22, channel 330); “microfluidic channel IV” (Page 143, line 23, waste channel 336).
Ermantraut does not teach “the microfluidic channel I, the microfluidic channel II and the microfluidic channel III respectively include an inflection point which is close to the center of the chip body relative to the corresponding liquid outflow chamber.”.
Xu teaches a full-integrated blood biochemical detection chip in addition to “the microfluidic channel I, the microfluidic channel II and the microfluidic channel III respectively include an inflection point which is close to the center of the chip body relative to the corresponding liquid outflow chamber.”. (Fig 3 and Page 4, bends in micro-flow passage 13, micro flow passage 11, micro flow passage 9, and micro flow passage 7).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ermantraut to incorporate the teachings of Xu wherein the microfluidic channels I-IV have an inflection point which is closer to the chip body. Doing so would increases the performance of the channel without needing additional parts this includes improving the mixing capability of the device.
Regarding claim 5, modified Ermantraut teaches all of claim 1 as above in addition to “the reaction chamber are respectively communicated with the vent holes.” (Page 118 line11-12, A reaction chamber of a device used in the method may further comprise one or more openings.
Ermantraut does not teach “wherein the quantitative mixing chamber and” has a vent hole.
Xu teaches full-integrated blood biochemical detection chip in addition to a “wherein the quantitative mixing chamber” has a vent hole which could be used for communication with another chamber or channel. (Page 3, two exhaust holes are opened on the side wall of said main body, wherein said vent hole is connected with the mixed tank by a fifth micro-channel).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ermantraut to incorporate the teachings of Xu wherein the quantitative mixing chamber has a vent. Doing so would decrease the number of air bubbles within the chamber in addition to allow for fluid transfer based on the position of the vents in reaction to the vents within the reaction chamber.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Ermantraut et. al. (WO 2009013321 A2) in view of Kang (CN 109999931 A), machine translation as applied to claim 1 above, and further in view of Wang et. al. (US 20170144150 A1).
Regarding claim 10, modified Ermantraut teaches all of claim 1 as above but does not teach “wherein the chip has a fan-shaped structure.”.
Wang teaches manufacturing and packaging a chip such as a biochip and a microfluidic chip in addition to “wherein the chip has a fan-shaped structure.” (Para [0034], The shape of the first and the second layers of the chip can be round, rectangular, annular, or fan-shaped.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ermantraut to incorporate the teachings of Wang wherein the wherein the chip has a fan-shaped structure. Doing so would increase fluid flow and mixing of the fluid within the chip.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Ermantraut et. al. (WO 2009013321 A2) in view of Kang (CN 109999931 A), machine translation as applied to claim 1 above, and further in view of Xiao et. al. (CN 108855264 A), machine translation.
Regarding claim 11, modified Ermantraut teaches all of claim 1 as above in addition to “wherein the chip further includes a chip upper layer and a chip middle layer, and the chip body” (Fig. 3, three layers).
However modified Ermantraut does not explicitly teach that “the chip body is located at lower layer.”
Xiao teaches multifunctional multi-index micro-fluidic chip in addition to “the chip body is located at lower layer.” (Fig. 2, lower plate 201).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ermantraut to incorporate the teachings of Xiao wherein the third layer is the body of the chip. Doing so would increase fluid flow and mixing of the fluid within the chip.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Ermantraut et. al. (WO 2009013321 A2) in view of Kang (CN 109999931 A), machine translation as applied to claim 1 above, and further in view of Yamauchi et. al. (CN 111372888 A), machine translation.
Regarding claim 12, modified Ermantraut teaches all of claim 1 as above but does not teach “wherein two sides of the chip body are respectively provided with a splicing slot.”.
Yamauchi teaches a microfluidic chip is formed with a flow path in addition to “wherein two sides of the chip body are respectively provided with a splicing slot.” (Page 13 and Fig 12, The FIG. 12 modifications, with the microfluidic chip 121 of the splicing member 124 overlapping the upper end face configuration is splicing components through contact with the upper end surface of the adhesive member 122, capable of bonding a bonding component on the upper surface of the flow path 122.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ermantraut to incorporate the teachings of Yamauchi wherein two sides of the chip body are respectively provided with a splicing slot. Doing so allows the connection of other components to the chip.
Conclusion
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/V.E.H./Examiner, Art Unit 1798
/JILL A WARDEN/Supervisory Patent Examiner, Art Unit 1798