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 .
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 “spike component” on the surfaces of the oil injection cavity and the at least one liquid injection cavity as recited in claim 1, “respective spike component” in the reagent bubble cap and “spike component” in the oil bubble cap in claims 12 and 15, 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 Interpretation
In the patentability analysis of apparatus claims 1-11 and 16-18, aspects or limitations examiner interprets as functional/process/intended use/ and/or not positively recited as part the claimed apparatus have been generally italicized whereas aspects interpreted as positively recited structural components are normally bolded. The bold font and italics are shown when the structure and function are initially introduced though not necessarily repeated, particularly in dependent claims. The examiner applies this formatting for both the examiner and applicant’s convenience. However, absent the referenced typestyles, the patentability analysis will still be clear regarding which limitations the examiner interprets as structural versus functional/process/intended use and/or not positively recited structure. Also note that it has been held that recitations in which an element is "adapted to/for", “configured to/for”, “positionable”, “moveable/immovable”, etc., only requires the ability to so perform (i.e., functional/process/intended use). The functional/process/intended use and/or elements not positively recited as part of the apparatus do not constitute a limitation in any patentable sense with respect to the prior art. Please note these recitations have not been ignored by the examiner. All of the claimed recitations in applicant’s claims 1-11 and 16-18 have been considered by the examiner and afforded the appropriate amount of patentable weight. In certain instances during prosecution, the examiner’s current interpretations regarding the patentable weight of these limitations might change based on the facts of the case.
The examiner's patentability analysis below provides one or more interpretations and claim mappings of the claimed structures and steps although other interpretations may be possible. In the patentability analysis, the Office applies the broadest reasonable interpretation (BRI) consistent with the specification and specific limitations from the specification have not been read into the claims.
See MPEP at least §2111.02, 2173.01 I 2114, and 2173.05(g).
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.
Claims 1-18 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, regards as the invention.
Claim 1 recites “a conductive cover”. It is not clear from the claim or the what applicant means by “conductive”. It is not clear if this referring a thermally, electrically, and/or light conductive cover. Applicant’s specification only appears to support a transparent conductive cover made of glass (see para [0047] of applicant’s corresponding US 2025/0010297; hereinafter ‘297). The examiner recommends including the limitation of “transparent” conductive cover for clarity and support.
Claim 1 also recites “at least one side-by-side” arranged liquid injection cavity. It is not clear how one liquid injection cavity is side-by-side another cavity. The examiner recommends applicant claim at least two liquid injection cavities.
The claims recite the “arranged”, which implies that the claim may be a product by process or method of making. For example, claim 1 recites “wherein the oil injection cavity, the sample dosing cavity and the at least one liquid injection cavity are used to arrange an oil bubble cap, a sample dosing plug and at least one reagent bubble cap” and “an oil injection column is arranged in the oil injection cavity”. The examiner recommends replace this language with comprising or includes for clarity. For similar reasons, the use of word “forms” in the claims is confusing and indefinite.
Claim 12 recites the step of “regulating a voltage of the microelectrode array arranged on the base plate of the microfluidic chip substrate”. This is confusing and indefinite since the method depends on the device of claim 1 and the device of claim 1 does not include microelectrode array or an means to regulate the voltage to the microelectrode array. Same deficiency was found in claim 15. This is confusing and indefinite.
Claim 18 recites “the liquid injection channel has an inclination, wherein the inclination of the liquid injection channel is between 5-10⁰. It is not clear along what axis or plane element of the microfluidic chip the angle of inclination is measured against. In addition, claim 18 includes the alternative language “and/or”. While this is not improper it can be confusing since the aluminum foil is not required and therefore does not limit the parent claim. The examiner recommends including this limitation in a new dependent claim for the sake of clarity.
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.
(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 1-5, 8-10, 12, and 15-17, as best understood, are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Kayyem et al., (US 2016012437; hereinafter “Kayyem”).
Regarding claim 1, Kayyem teaches a microfluidic chip 10 comprising;
a microfluidic chip substrate (corresponds substrate 356 with electrode array thereon, see para [0180] et seq.),
a conductive cover (transparent plate 241, Kayyem teaches a glass substrate; see para [0111], [0164] et seq.), and
a liquid injection housing (which corresponds to housing 12 with sample preparation module 70 including cavities for receiving a sample well 78 formed in the substrate 72, plurality of deformable compartments (or blisters) 34a, 36a, 38a, 40a, 42a, and 44, substrate 56 and sample preparation substrate 72. Each deformable compartment may contain a fluid and may be connected to a fluid channel within the sample preparation module 70, via one of the inlet ports, by an openable connection (e.g., lance; see para [0121] et seq.) that is initially closed to prevent fluid from flowing from the blister into the channels; see para [0115] et seq.),
which are sequentially stacked from bottom to top, wherein the liquid injection housing is provided with at least one liquid injection conduit (inlet port) and an oil intake conduit (inlet port) see Figs. 3 and 4) ;
wherein the liquid injection housing comprises
an oil injection cavity (38a see para [0142] et seq.),
a sample dosing cavity (sample chamber/well 78; see Fig. 3), and
at least two liquid injection cavities disposed side-by-side (containing deformable compartment or blisters, see 36a, 34a, 36a, 40a, 42a, and 44),
wherein the oil injection cavity, the sample dosing cavity and the at least one liquid injection cavity are used to arrange an oil bubble cap, a sample dosing plug and at least one reagent bubble cap (deformable blisters or compartments36a, 34a, 36a, 40a, 42a, and 44), respectively;
a liquid injection column (interpreted as inlets and channels) connected to a corresponding one of the at least one liquid injection conduit arranged respectively in each of the at least one liquid injection cavity (see para [0013] et seq., each deformable compartment may contain a fluid and may be connected to a fluid channel within the sample preparation module 70, via one of the inlet ports, by an openable connection that is initially closed to prevent fluid from flowing from the blister into the channel. and
each of the at least two liquid injection conduits form liquid injection channels (reads on inlets and channels) ; an oil injection column is arranged in the oil injection cavity and is connected to the oil intake conduit; and
surfaces of the oil injection cavity and the at least one liquid injection cavity are each correspondingly provided with a spike component (e.g., lance; see para [0121] et seq.)
Regarding claim 2, Kayyem teaches at least one venting conduit is arranged on the liquid injection housing, the liquid injection housing is provided with at least one vent, and the at least one vent is each in communication with one of the at least one venting conduit (see para [0167] et seq.)
Regarding claim 3, Kayyem teaches the microfluidic chip substrate and the conductive cover are connected to each other by using a gap sealant circumferentially arranged between the microfluidic chip substrate and the conductive cover, and a closed cavity 295 is formed by the microfluidic chip substrate, the conductive cover and the gap sealant (see para [0111] et seq.)
Regarding claim 4, Kayyem teaches the conductive cover is provided with at least one through hole, the at least one through hole is in communication with the inside of the closed cavity, the at least one through hole comprises at least one liquid intake hole, a sample intake hole and an oil intake hole, and the at least one liquid intake hole and the oil intake hole are aligned with the at least one liquid injection conduit and the oil intake conduit, respectively (see Fig. 26-29).
Regarding claim 5, Kayyem teaches the conductive cover is provided with at least one through hole, the at least one through hole is in communication with the inside of the closed cavity, the at least one through hole comprises a vent, and the vent is aligned with a corresponding venting conduit arranged on the liquid injection housing (see para [0168] et seq.)
Regarding claim 8, Kayyem teaches the conductive cover is a transparent conductive cover (see para [0111] et seq.)
Regarding claim 9, Kayyem teaches the conductive cover is bonded to the liquid injection housing by means of an adhesive, and an edge of the liquid injection housing is bonded to an edge of the microfluidic chip substrate by means of an adhesive to form a seal (see para [0111] et seq.)
Regarding claim 10, Kayyem teaches the microfluidic chip substrate comprises a base plate 354, a microelectrode array is arranged on the base plate, and a dielectric layer and a hydrophobic layer are sequentially stacked on the microelectrode array corresponds to fluidic processing panels, 241 354 with electrode array thereon) see para [0180] et seq.
Regarding claim 12, as best understood, Kayyem teaches a liquid injection method comprising: during liquid injection, the liquid injection column continuously entering a corresponding reagent bubble cap to press a liquid in the reagent bubble cap, the reagent bubble cap forming a seal with the liquid injection column in the downward pressing process, piercing the reagent bubble cap by the respective spike component, the liquid in the reagent bubble cap flowing into the closed cavity of the microfluidic chip through the liquid injection channel, and regulating a voltage of the microelectrode array arranged on the base plate of the microfluidic chip substrate (see para [0192] et seq.), such that the liquid flowing from the reagent bubble cap to the closed cavity reaches a designated position; and during oil injection, the oil injection column continuously entering the oil bubble cap to press a liquid in the oil bubble cap, the oil bubble cap forming a seal with the oil injection column in the downward pressing process, piercing the oil bubble cap by the respective spike component, the liquid in the oil bubble cap flowing into the closed cavity of the microfluidic chip through the oil intake hole, and regulating the voltage of the microelectrode array arranged on the base plate of the microfluidic chip substrate, such that the oil liquid flowing from the oil bubble cap to the closed cavity reaches a designated position (see para [0192] et seq.)
Regarding claim 15, as best understood, Kayyem teaches an oil injection method for a microfluidic chip according to claim 1 the oil injection method comprising: during liquid injection, the liquid injection column continuously entering a corresponding reagent bubble cap to press a liquid in the reagent bubble cap, the reagent bubble cap forming a seal with the liquid injection column in the downward pressing process, piercing the reagent bubble cap by the respective spike component, the liquid in the reagent bubble cap flowing into the closed cavity of the microfluidic chip through the liquid injection channel, and regulating a voltage of the microelectrode array arranged on the base plate of the microfluidic chip substrate, such that the liquid flowing from the reagent bubble cap to the closed cavity reaches a designated position; and during oil injection, piercing the oil bubble cap by the respective spike component in the downward pressing process, and the liquid in the oil bubble cap flowing into the closed cavity of the microfluidic chip through the oil intake hole (see para [0192] et seq.)
. Claim 16 recites the microfluidic chip being used in the field of digital microfluidic chips. This a functional/process and/or intended use claim which has not receive any patentable weight for the reasons delineated above.
Regarding claim 17, Kayyem teaches the conductive cover 241 is made of glass (see para [0162] et seq.) .
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 6, 7, 11, 13, 14 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Kayyem.
Regarding claim 6, Kayyem does not specifically teach the at least one through hole is arranged at a distance of 0.5-1 mm from an edge of the conductive cover. However, it would have been obvious to one of ordinary skill in the art at the time the claimed invention was effectively filed to have determined the location of the through hole on the conductive cover in Kayyem for optimum throughput and overall footprint. Applicant is advised that the Supreme Court has clarified that a claim can be proved obvious merely by showing that the combination of known elements was obvious to try. In this regard, the Supreme Court explained that “[w]hen there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill in the art has a good reason to pursue the known options within his or her technical grasp.” An obviousness determination is not the result of a rigid formal disassociated from the consideration of the facts of the case. Indeed, the common sense of those skilled in the art demonstrates why some combinations would have been obvious where others would not. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. The location is one of several straightforward design possibilities which the skilled artisan would select, depending of the circumstances, without exercising inventive skill in order to solve the problem posed. See KSR Int’l v. Teleflex Inc., 127 Sup. Ct. 1727, 1742, 82, USPQ2d 1385, 1397 (2007), see MPEP 2143). The examiner submits that these reasons are in line with the Supreme Court unanimous opinion, which the Court stated that “[a] court must ask whether the improvement is more than a predicable use of the prior art elements according to their established functions”. Similar reasoning applies to claims 7, 11, 13-15 and 18 (which is confusing), which are directed to sizes and steps of operation which would also be obvious to determine without exercising inventive skill in order to sample the problem posed.
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
No claims are allowed.
While the following prior art listed below is not specifically discussed in this Official action, the examiner considers the listed prior art relevant to the overall prosecution and may be relied upon during subsequent examination(s) based on applicant’s future response(s).
i. Kayyem et al. (US 2018/0223345) teach biochip cartridges comprising a bottom substrate and a top plate. The bottom substrate comprises a printed circuit board (PCB) comprising an electrowetting grid of electrodes forming a droplet pathway, an array of detection electrodes accessible to the droplet pathway, each comprising a self-assembled monolayer and a capture probe, and a plurality of interconnections from the electrowetting grid and the detection electrodes. The top plate comprises a conductive surface substantially parallel to the bottom substrate and mated thereto to form a reaction chamber.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to P. Kathryn Wright whose telephone number is (571)272-2374. The examiner can normally be reached between 9:30am-7pm EST.
Examiner interviews are available via telephone 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.
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 on 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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/P. Kathryn Wright/Primary Examiner, Art Unit 1798
Prosecution Insights