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). The certified copy has been filed in parent Application No. EP21205300.3, filed on 10/28/2021.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
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.
Claim(s) 16-32 are rejected under 35 U.S.C. 102(a)(1) based upon a public use or sale or other public availability of the invention.
The instant invention is anticipated by Wakeley et al. (US20120270225A1).
Regarding Claim 16, Wakeley et al. teaches a microfluidic element for processing a quantity of liquid (See the Abstract, the device 1, and the Claim(s) 37-57 in [0018]-[0136] in Fig. 1-8), comprising: a channel region (See the channels 12, 13, 14, 15, and 16 that link the wells, and the additional channels 17-22 that link most of the wells to pneumatic ports 23-28 provided in the upper cover 3 of the housing 1 in [0018], [0099] in Fig. 1); and
a dry reagent arranged in an outwardly open end portion of the channel region so that the liquid comes in contact with the dry reagent (See how the sample plug 33 is then inserted into the sample well 6, and how the plug 34 carries reagents such as amplification specific primers, enzymes etc. needed to carry out an amplification reaction dried onto an outer surface thereof is then inserted into the well 8 acting as amplification chamber in [0074], [0102]-[0116] in Fig. 1).
Regarding Claim(s) 17-18, Wakeley et al. teaches the element limitations of claim 16.
Wakeley et al. further teaches a microfluidic element for processing a quantity of liquid (See the Abstract, the device 1, and the Claim(s) 37-57 in [0018]-[0136] in Fig. 1-8), wherein the microfluidic element is a flow cell (See in Fig. 1-8);
wherein the channel region has a further outwardly open end portion that is in fluid communication with the end portion for introducing the quantity of liquid into the microfluidic element (See the combination of the sample plugs 33,34, the openings 29,30, and the wells 6,8 in [0074], [0099]-[0116] in Fig. 1).
Regarding Claim(s) 19-21, Wakeley et al. teaches the element limitations of claim 18.
Wakeley et al. further teaches a microfluidic element for processing a quantity of liquid (See the Abstract, the device 1, and the Claim(s) 37-57 in [0018]-[0136] in Fig. 1-8), wherein the end portion and/or the further end portion are each bounded inward by a constriction of a cross-section of the channel (See how at least a portion of the membrane 31 extends across the openings 29,30 in the cover 3, and how a cutter 'not shown' is adapted to cut a sample from the membrane 31 extending across the opening 30 of the well 8 as the plug 34 is pushed into the well. The cut sample then drops into the well 8 ready for amplification in [0076], [0102]-[0104] in Fig. 1);
wherein the constriction is permeable for air but impermeable for liquid at ambient pressure (See the cover 3 and the membrane 31 in [0104]-[0112] in Fig. 1);
wherein the end portion and/or the further end portion of the channel region is a capillary channel (See how the bibulous membrane 31 is arranged within a horizontal passage in the body 2 and extends between well 7 and well 8, so that liquid within well 7 will wick along the membrane towards well 8 in [0074], [0100]-[0102], [0111] in Fig. 1).
Regarding Claim(s) 22-23, Wakeley et al. teaches the element limitations of claim 21.
Wakeley et al. further teaches a microfluidic element for processing a quantity of liquid (See the Abstract, the device 1, and the Claim(s) 37-57 in [0018]-[0136] in Fig. 1-8), wherein the capillary channel is hydrophobized (See the use of hydrophobic materials in [0061]-[0062]);
further comprising a base body, wherein the end portion and/or the further end portion is formed in a projection that protrudes from the base body (See the combination of the sample plugs 33,34, the openings 29,30, and the wells 6,8 of the central block 2 and the lower base plate 4 in [0074], [0099]-[0116] in Fig. 1).
Regarding Claim(s) 24-25, Wakeley et al. teaches the element limitations of claim 23.
Wakeley et al. further teaches a microfluidic element for processing a quantity of liquid (See the Abstract, the device 1, and the Claim(s) 37-57 in [0018]-[0136] in Fig. 1-8), wherein the projection protrudes perpendicularly from the base body (See the combination of the sample plugs 33,34, the openings 29,30, and the wells 6,8 of the central block 2 and the lower base plate 4 in [0074], [0099]-[0116] in Fig. 1);
wherein the projection is formed integrally with a substrate that the base body (See the central block 2 and the lower base plate 4 in [0099] Fig. 1) comprises, or the end portion with the dry reagent is formed in a separate carrier element that at least partially forms the projection and is connected to the microfluidic element by adhesive bonding, welding and/or press fitting (See the combination of the sample plugs 33,34, the openings 29,30, and the wells 6,8 in [0074], [0099]-[0116] in Fig. 1).
Regarding Claim(s) 26-28, Wakeley et al. teaches the element limitations of claim 18.
Wakeley et al. further teaches a microfluidic element for processing a quantity of liquid (See the Abstract, the device 1, and the Claim(s) 37-57 in [0018]-[0136] in Fig. 1-8), wherein the end portion is externally covered by a breakable film or a gas-permeable but liquid-impermeable membrane (See the cover 3 and the membrane 31 in [0100]-[0112] in Fig. 1);
wherein the channel region has at least one chamber (See how the central block 2 includes a number of wells 5-11 therein together with channels 12-16 linking the wells in [0099] in Fig. 1);
wherein the microfluidic element is at least partially transparent for optical measurements at least in a region of the chamber (See in [0046], [0127]).
Regarding Claim 29, Wakeley et al. teaches a method for producing a microfluidic element with an integrated dry reagent (See the Abstract, the device 1, and the Claim(s) 37-57 in [0018]-[0136] in Fig. 1-8), comprising the steps of: arranging the dry reagent in an outwardly open end portion of a channel region; and forming the end portion from a projection that protrudes from a base body of the microfluidic element (See in [0099]-[0116] in Fig. 1).
Regarding Claim(s) 30-31, Wakeley et al. teaches the method limitations of claim 29.
Wakeley et al. further teaches a method for producing a microfluidic element with an integrated dry reagent (See the Abstract, the device 1, and the Claim(s) 37-57 in [0018]-[0136] in Fig. 1-8), further including filling the end portion, which is configured as a capillary channel, from outside with a reagent liquid and subsequently drying with adhesion the dry reagent to a channel wall (See in [0048], [0064]-[0089] and in claim 47);
further including finally covering the end portion with a breakable film (See the membrane 31 in [0104]-[0112] in Fig. 1).
Regarding Claim 32, Wakeley et al. teaches the element limitations of claim 18.
Wakeley et al. further teaches a combination (See the Abstract, the device 1, and the Claim(s) 37-57 in [0018]-[0136] in Fig. 1-8), comprising: of a microfluidic element (See Fig. 1); and devices for operating the microfluidic element, the devices having a controllable pressure source for attachment to the further end portion that is intended to receive the quantity of liquid, and a passive pressure source comprising a closed compression space for attachment to the end portion that has the dry reagent (See the vacuum pressure system, the nucleic acid extraction system, the nucleic acid purification system, the nucleic acid extraction and purification system, and the apparatus in [0053]-[0086] in Fig 1-8 and in claim(s) 37-55).
Note what is discussed in MPEP § 2144 VI. concerning the rearrangement of parts of a claimed invention in comparison to the prior art. In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950) (Claims to a hydraulic power press which read on the prior art except with regard to the position of the starting switch were held unpatentable because shifting the position of the starting switch would not have modified the operation of the device.); In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975) (the particular placement of a contact in a conductivity measuring device was held to be an obvious matter of design choice). The current claims regarding the location of the pressure source in relation to the end portion, does not change the function of the claimed invention in comparison to the prior art. Thus, the prior art still reads on claim 32.
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.
Claim 33 is rejected under 35 U.S.C. 103 as being unpatentable over Wakeley et al. (US20120270225A1) as applied to claim 16 above, and further in view of Weber (US20120082599A1).
Regarding Claim 33, Wakeley et al. teaches the element limitations of claim 16.
Wakeley et al. further teaches a method for operating a microfluidic element by operating devices (See the Abstract, the device 1, and the Claim(s) 37-57 in [0018]-[0136] in Fig. 1-8), comprising the steps of: connecting a controllable pressure source to the further end portion of the channel region of the microfluidic element (See the vacuum pressure system, the nucleic acid extraction system, the nucleic acid purification system, the nucleic acid extraction and purification system, and the apparatus in [0053]-[0086] in Fig 1-8 and in claim(s) 37-55);
connecting a passive pressure source to the end portion of the microfluidic element that contains the dry reagent; introducing a quantity of liquid into the further end portion; and displacing the quantity of liquid by the controllable pressure source against a rising pressure of the passive pressure source into the end portion that contains the dry reagent, in order to dissolve the dry reagent (See in [0018]-[0136] in Fig. 1-8).
Wakeley et al. fails to explicitly teach a method for operating a microfluidic element according to claim 16 by operating devices, comprising the steps of: connecting a passive pressure source to the end portion of the microfluidic element that contains the dry reagent; and displacing the quantity of liquid by the controllable pressure source against a rising pressure of the passive pressure source into the end portion that contains the dry reagent, in order to dissolve the dry reagent.
However, in the analogous art of apparatuses for transporting a fluid within a channel leg of a microfluidic element, Weber teaches a method for operating a microfluidic element by operating devices (See the Abstract, the plate-shaped flow cell device, and the claim(s) 16-30 in [0001]-[0075] in Fig. 1-11), comprising the steps of: connecting a controllable pressure source to the further end portion of the channel region of the microfluidic element (See the external pressure sources and air spring, in [0006]-[0022], [0045]-[0057], [0060]-[0075] in Fig. 1-11);
connecting a passive pressure source to the end portion of the microfluidic element that contains the dry reagent; (See the air spring with a chamber 22 which is covered by a flexible diaphragm 23 in [0060]-[0075] in Fig. 6-11; Also, see the dry reagents in [0017], [0039], [0051] in Fig. 3);
introducing a quantity of liquid into the further end portion; and displacing the quantity of liquid by the controllable pressure source against a rising pressure of the passive pressure source into the end portion that contains the dry reagent, in order to dissolve the dry reagent (See in claim(s) 16-30).
Thus, it would be obvious to one with ordinary skills in the arts to modify and/or combine the method of Wakeley et al. by incorporating a passive pressure source with multiple flow cell connections (as taught by Weber) for the benefit of transporting both liquid and dry samples in a microfluidic element.
Further, Note what is discussed in MPEP § 2144 VI. concerning the rearrangement of parts of a claimed invention in comparison to the prior art. In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950) (Claims to a hydraulic power press which read on the prior art except with regard to the position of the starting switch were held unpatentable because shifting the position of the starting switch would not have modified the operation of the device.); In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975) (the particular placement of a contact in a conductivity measuring device was held to be an obvious matter of design choice). The current claims regarding the location of the pressure source in relation to the end portion, does not change the function of the claimed invention in comparison to the prior art. Thus, the prior art still reads on claim 33.
Allowable Subject Matter
Claim(s) 34-35 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Regarding Claim(s) 34-35, The combination of Wakeley et al. and Weber teaches the method limitations of claim 33.
Though Weber discloses a method for operating a microfluidic element by operating devices (See the Abstract, the plate-shaped flow cell device, and the claim(s) 16-30 in [0001]-[0075] in Fig. 1-11), comprising the steps of: connecting a controllable pressure source to the further end portion of the channel region of the microfluidic element (See the external pressure sources and air spring, in [0006]-[0022], [0045]-[0057], [0060]-[0075] in Fig. 1-11); connecting a pressure source to the end portion of the microfluidic element that contains the dry reagent; (See the air spring with a chamber 22 which is covered by a flexible diaphragm 23 in [0060]-[0075] in Fig. 6-11; Also, see the dry reagents in [0017], [0039], [0051] in Fig. 3 and in claim(s) 16-30); pressure equilibrium between connected pressure sources (See in claim(s) 22-23); reagent position determination using pressure (See in claim 21); the decoupling of the microfluidic element from pressure sources (See in claim(s) 18 and 28); and a detection region (See in claim 26).
The combination of Wakeley et al. and Weber fails to explicitly teach or fairly suggest a method, including keeping the pressure of the controllable pressure source constant in order to hold the quantity of liquid, if appropriate with redissolved reagent, inside the channel region with a pressure equilibrium between the pressure sources in a desired position dependent on the constant pressure; and including decoupling the microfluidic element from the operating devices by reducing the pressure of the pressure sources to atmospheric pressure while maintaining the pressure equilibrium, and positioning the quantity of liquid in a detection region after the redissolving of the dry reagent. Neither Wakeley et al. and Weber discuss creating pressure equilibriums between pressure sources to position or dissolve reagents of choice in the channel region or the detection region. Thus, claim(s) 33 and 34 are in condition for allowance.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRITNEY N. WASHINGTON whose telephone number is (703)756-5959. The examiner can normally be reached Monday-Friday 9:00am - 5:30pm CT.
Examiner interviews are available via telephone, in-person, 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.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lyle Alexander can be reached at (571) 272-1254. 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.
/BRITNEY N. WASHINGTON/Examiner, Art Unit 1797
/JENNIFER WECKER/Primary Examiner, Art Unit 1797
Prosecution Insights