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 .
This action is in response to papers filed June 01, 2023. Any previous objection/ rejection not repeated herein has been withdrawn.
Claim Interpretation
In the patentability analysis of apparatus and method claims 1-20, aspects or limitations examiner interprets as functional/process/intended use/ or not positively recite 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 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 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 1-20 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 limitation might change based on the facts of the case.
The examiner's below patentability analysis 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 § 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 1-10, 12, 13 and 15-16 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Knight et al., (US 2012/0052560; hereinafter “Knight)
As to claim 1, Knight teaches an apparatus of loading and imaging at least one microfluidic chip comprising:
a housing having walls that define a vacuum chamber (instrument 300 has a frame chassis 302 and a processing drawer 304);
a first receptacle disposed within the vacuum chamber, (first receptacle has been interpreted as space within the chamber in which a tray 314 for receiving the one or more microfluidic chips- as consistent with applicant’s claim 3 and the term “vacuum” is not considered a structural element that limits the chamber), (see Fig. 5 and para [0132] et seq.);
a negative pressure source coupled to the housing (see para [0141] et seq.) and configured to reduce pressure within the vacuum chamber;
a light source 118 (a3-a5) coupled to the housing (see Fig 3 para [0116] et seq.) and positionable to illuminate at least a portion of the space for receiving the microfluidic chip 328 having microfluidic channels 364 (if not clear, the microfluidic chip as claimed is not positively recited as of the apparatus and does not limit the apparatus); and
an optical sensor 118(b1-2) coupled to the housing (see para [0116] et seq.) and positionable to capture an image of at least a portion of the space for receiving the at least one microfluidic chip.
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As to Regarding claim 2, Knight teaches at least one of the walls defines an opening and the housing comprises a door that is movable between an open position in which the door permits access to the vacuum chamber through the opening and a closed position in which the door prevents access to the vacuum chamber through the opening (see modified Fig. 5 above)
As to claim 3, Knight teaches a tray (which can be drawer or the tray 314 in the drawer) that is movable into and out of the vacuum chamber through the opening, wherein the first receptacle is defined by the tray (see para [0132] et seq.)
As to claims 4 and 5, Knight teaches the tray is slidably coupled to at least one of the walls of the housing, (see drawer see para [0034] et seq.) and coupled to the door such that movement of the door between the open and closed position moves the tray into and out of the chamber, see modified Fig. 5 above).
Claims 6 and 9 are directed to a process/functional recitations. Nevertheless, Knight teaches while the door is in the closed position, the first receptacle is immovable in at least two orthogonal directions relative to at least one of the walls of the housing, Knight teaches the processing drawer 304 may also be computer-controlled to remain closed (and, optionally, locked) during a procedure while the instrument is running and to open automatically at the completion of the procedure (see para [0133] et seq.), and the optical sensor is movable in at least two orthogonal directions relative to at least one of the walls of the housing (see para [0222] et seq.)
Regarding claim 7, Knight shows a seal (no reference number but shown in Fig. 5) coupled to the housing such that, when the door is in the closed position: the seal is disposed around the opening and in contact with the door; and of course reducing pressure within the vacuum chamber would urge the door against the seal. However, if applicant disagrees that Fig. 5 of Knight shows a seal, then the examiner takes Official Notice that seals are well known and understood in the art in chamber that include a temperature control system.
Regarding claim 8, Knight teaches at least one of the walls of the housing includes a transparent portion; and the optical sensor is disposed outside of the vacuum chamber and is positioned to capture an image of at least a portion of the space for receiving the microfluidic chip(s) through the transparent portion. Specifically Knight teaches the optical system 310 may be located below processing drawer 304, which would require the bottom of the processing drawer to be transparent to capture an image of the transparent side of the microfluidic chip (see para [0131], [0230] et seq.)
As to claim 10, Knight teaches a heating element 120a disposed within the vacuum chamber (see para [0114] et seq.)
Regarding claim 12, Knight teaches method of loading and imaging a microfluidic chip, the method comprising:
disposing one or more microfluidic chips within a vacuum chamber, the vacuum chamber defined by walls of a housing (process drawer in fluid communication with vacuum manifold; see para [0257] et seq.),
each of the chip(s) having one or more microfluidic networks that each includes: one or more ports, including an inlet port containing liquid (see Fig. 9);
a test volume containing gas (channel); and
a flow path extending between the inlet port and the test volume, the flow path including a droplet-generating region along which a minimum cross-sectional area of the flow path increases along the flow path (see Fig. 9, where channel connected to inlets 349 is larger flow path 356a);
reducing pressure within the vacuum chamber such that, for each of the network(s) of each of the chip(s), gas flows from the test volume and out of at least one of the port(s) (see para [0108] et seq.);
increasing pressure within the vacuum chamber such that, for each of the network(s) of each of the chip(s), liquid flows from the inlet port, through the flow path, and into the test volume (see para [0191] et seq.); and
for each of the network(s) of each of the chip(s), capturing an image of liquid via imaging system 310 within the test volume while the chip is disposed within the vacuum chamber.
Regarding claim 13, Knight teaches while the door is in the closed position, the first receptacle is immovable in at least two orthogonal directions relative to at least one of the walls of the housing, Knight teaches the processing drawer 304 may also be computer-controlled to remain closed (and, optionally, locked) during a procedure while the instrument is running and to open automatically at the completion of the procedure (see para [0133] et seq.)
Regarding claims 15 and 16, Knight teaches at least one of the walls of the housing includes a transparent portion; and the optical sensor is disposed outside of the vacuum chamber and is positioned (coupled) to capture an image of at least a portion of the space for receiving the microfluidic chip(s) through the transparent portion. Specifically Knight teaches the optical system 310 may be located below processing drawer 304, which would require the bottom of the processing drawer to be transparent to capture an image of the transparent side of the microfluidic chip (see para [0131], [0230] 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 11, 14 and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Knight.
Regarding claims 11 and 20, Knight does not specifically disclose the apparatus comprises a second receptacle disposed within the vacuum chamber, the second receptacle defining a space for receiving one or more microfluidic chips; or the first receptacle defines a space for receiving two or more microfluidic chips. However, it would have been obvious to include an additional receptacle to receive an additional microfluidic chips capabilities to Knight in order to increase apparatus throughput. Furthermore, it has been held that the mere duplication of the essential working parts of a device involves only routine skill in the art, see MPEP 2144.04(VI)(B).
With regard to the order of steps, the courts have ruled that the selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results, (see MPEP 2144.04 section IV C). In the instant case, as discussed below, the reference discloses the claimed method steps, and thus, is prima facie obvious in the absence of new or unexpected results.
Regarding claim 14, Knight does not specifically disclose that the optical sensor is movable relative to at least one of the walls of the housing in at least two orthogonal directions. However, it would have been obvious to one of ordinary skill in the art at the time the claimed invention was effectively filed to include in the optical sensor of K
Regarding claims 17-19, are directed to steps that would have been obvious to one of ordinary skill in the art to determine through routine experimentation using the apparatus of Knight in an effort to optimize the operational parameters of the loading and imaging a microfluidic chips, in which these parameters include time, temperature, pressure, throughput, and do not provide any unexpected results to the operation of loading and imaging microfluidic devices.
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. Boronkasy et al., (US 2006/0163070) teach a priming unit 31 seen in FIG. 4 that includes a base 32 and a top 33, joined by a hinge connection at the rear of the base. The unit is shown in an open position, and is closed by rotating the top down in the direction of the arrow 34. To prepare the unit for priming of a microfluidics device, one or more of the reservoirs of the carrier holding the microfluidics device is filled with the priming fluid, whether the fluid be a gel or liquid. This can be done by pipette either before or after the carrier has been placed inside the priming unit but before the priming unit has been closed over the carrier. Once the priming unit is closed, the supply lines in the priming unit are engaged with the microfluidics device in the carrier. The priming unit forms a pressure seal over the reservoirs, thereby sealing the fluid in the reservoirs and allowing the reservoirs to be pressurized with pressure generated inside the priming unit.
II. Levner et al., (US 2018/0016536) teach s perfusion manifold assembly showing the cover off of the reservoirs, the reservoirs above the backplane, the backplane in fluidic communication with the skirt, the skirt with a side track for engaging a representative microfluidic device or “chip” having one or more inlet, outlet and vacuum ports, the chip shown next to (but not in) one embodiment of a chip carrier, the carrier is configured to support and carrier the chip. FIG. 1B shows the same embodiment of the perfusion manifold assembly with the cover on and over the reservoirs, and the chip inside the chip carrier fully linked to the skirt of the perfusion manifold assembly, and thereby in fluidic communication with the reservoirs. FIG. 1C shows an exploded view of one embodiment of the cover assembly comprising a pressure cover or pressure lid, and an associated gasket thereunder.
III. Lee et al., (US 2017/0297020) which teach a molecular diagnostics system is provided with a microfluidic chip, detection apparatus and an integrated or wireless control interface and imager. The system provides automated sample preparation and rapid optical detection of multianalyte nucleic acids and proteins. On chip PCR may be performed to improve the optical fluorescence signal for nucleic acid detections.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/P. Kathryn Wright/Primary Examiner, Art Unit 1798
Prosecution Insights