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 .
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 8 and 19-22 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.
For claim 8, the phrase “prior to insertion into the housing” is unclear as the Examiner is unable to determine if the tray is heated prior to inserting the tray into the housing, or if the claim intends to recite preheating or precooling the tray prior to inserting the microfluidic device into the housing. As such, it is unclear what is being inserted into the housing with respect to the tray and the microfluidic device.
For claim 19, the claim is indefinite because it recites a process limitation in a claim directed to a device (MPEP 2173.05(p)). The limitations of “wherein the thermal energy source heats or cools the microfluidic device by overshooting the first temperature and then reducing the overshoot until the microfluidic device reaches the first temperature” is a process limitation. As set forth in the MPEP, process limitations in a claim directed to a device are indefinite as it is unclear whether infringement occurs when on makes the device, or whether infringement occurs when the device is utilized in the manner recited in the claim.
Claim 20 recites the limitation "the acceleration" in line 1. There is insufficient antecedent basis for this limitation in the claim. Additionally, the Examiner notes that claim 20 recites a process limitation in a claim directed to a device (MPEP 2173.05(p)). As set forth in the MPEP, process limitations in a claim directed to a device are indefinite as it is unclear whether infringement occurs when on makes the device, or whether infringement occurs when the device is utilized in the manner recited in the claim. As such, one cannot determine if infringement of claim 20 occurs when one makes the claimed device, or if infringement occurs when the claimed device is utilized in the manner recited in the claim.
For claim 21, the claim is indefinite because it recites a process limitation in a claim directed to a device (MPEP 2173.05(p)). The limitation of “the thermal energy source preheats or precools the tray prior to insertion into the housing” is a process limitation. As such, one cannot determine if infringement occurs when the claimed device is made, or if infringement occurs when one utilizes the device in the manner recited in the claim. Additionally, it is unclear if the claimed tray is a structural element of the device, or if the tray is a separate element, that is placed into the device prior to use.
For claim 22, the claim is indefinite because it recites a process limitation in a claim directed to a device (MPEP 2173.05(p)). The limitation of “the microfluidic device is placed in a thermally conductive holder” is a process limitation. As such, one cannot determine if infringement occurs when the claimed device is made, or if infringement occurs when one utilizes the device in the manner recited in the claim. Additionally, it is unclear if the claimed thermally conductive holder is a structural element of the device, or if the holder is a separate element that is placed in the device prior to use.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-3, 6, 7, 10, 12-18, and 19-22 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kimball et al., (US 2013/0078610).
For claim 1, Kimball et al., teach a method for thermal cycling of microfluidic samples comprising providing a thermal cycler for performing an assay at a first temperature (paragraph 0008) wherein the thermal cycler comprises a housing and a thermal chuck (tray, paragraph 0035) for holding the microfluidic device (paragraph 0035) wherein the thermal chuck comprises a thermal energy source (paragraph 0035). Kimball et al., teach the thermal cycler having an ambient temperature sensor (paragraph 0052) and a temperature sensor that measures the temperature of the microfluidic device (paragraph 0052). Kimball et al., also teach placing the microfluidic device in the thermal chuck (paragraph 0035), determining a difference between ambient temperature and the first temperature (paragraphs 0051, 0052), and heating the microfluidic device by overshooting the first temperature, and cooling until the microfluidic device meets the first temperature (paragraph 0064, figure 8A).
For claim 2, Kimball et al., teach a thermoelectric cooler (paragraph 0034) comprising a heatsink (paragraph 0029).
For claim 3, Kimball et al., teach thermistors as the temperature sensors (paragraphs 0040, 0049, 0052).
For claims 6 and 7, Kimball et al., heating the microfluidic device by overshooting the first temperature, and cooling until the microfluidic device meets the first temperature (paragraph 0064, figure 8A). With respect to claim 7, the prior art overshoot only occurs when the tray and microfluidic device are placed into the thermocycler, thus the overshoot is necessarily initiated when the tray is inserted into the thermocycler (paragraph 0064).
For claim 10, Kimball et al., teach ambient temperature at 25°C (paragraph 0052).
For claim 12, Kimball et al., teach the microfluidic device reaching a temperature within 1°C of the first temperature in less than 60 seconds (paragraph 0056).
For claim 13, Kimball et al., teach the microfluidic device reaching a temperature within 0.5°C of the first temperature in less than 60 seconds (paragraph 0056).
For claim 14, Kimball et al., teach a thermal cycler comprising a housing and a thermal chuck (tray, paragraph 0035) for holding the microfluidic device (paragraph 0035), and a thermal energy source (paragraph 0035). Kimball et al., also teach heating the microfluidic device by overshooting the first temperature, and cooling until the microfluidic device meets the first temperature (paragraph 0064, figure 8A).
For claim 15, Kimball et al., teach a thermoelectric cooler (paragraph 0034) comprising a heatsink (paragraph 0029).
For claim 16, Kimball et al., teach thermistors as the temperature sensors (paragraphs 0040, 0049, 0052).
For claims 17 and 18, Kimball et al., teach an infrared sensor (paragraph 0042).
For claims 19-22, the Examiner notes that the claims are being read in light of the rejections under 35 U.S.C 112(b) in which the claims are directed to a device, but recite process limitations. Because reference to Kimball et al., teach a device identical to that of the instant claims, the Examiner contends that the prior art device would be fully capable of performing the process limitations recited in claims 19-22.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kimball et al., (US 2013/0078610).
Regarding claim 11, Kimball et al., teach an ambient temperature of 25°C, but do not teach performing an assay at a first temperature ranging from 20°C to 25°C. The Examiner is reading this limitation as optimization by routine experimentation which would have been obvious to one of ordinary skill in the art (MPEP 2144.05 II A). The MPEP states that differences in concentration or temperature does not support patentability of subject matter encompassed by the prior art absent evidence indicating the concentration or temperature to be critical (MPEP 2144.05 II A). Reference to Kimball et al., is directed to nucleic acid amplification which occurs at temperatures higher than 20 to 25°C. However, one of ordinary skill in the art would have recognized that thermocyclers can be utilized for assays that require lower temperatures. As such, one of ordinary skill in the art would have found it obvious to set the first temperature at 20 to 25°C based on the assay being performed. Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Kimball et al., wherein the first temperature ranges from 20°C to 25°C as optimization requires only routine skill in the art.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kimball et al., (US 2013/0078610) in view of Mikkelsen et al., (US 2022/0275434).
Regarding claim 9, Kimball et al., do not teach placing the microfluidic device in a thermally conductive holder.
Mikkelsen et al., teach a method for amplifying nucleic acids wherein a microfluidic device is placed into a thermally conductive holder (paragraph 0083). Mikkelsen et al., teach that it is advantageous to utilize a thermally conductive holder as a means of cooling the microfluidic device to prevent temperature dependent reactions from occurring while the microfluidic device is placed into the system (paragraph 0083).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Kimball et al., wherein the microfluidic device is placed into a thermally conductive holder in order to prevent temperature dependent reactions from occurring in the microfluidic device as taught by Mikkelsen et al.
Allowable Subject Matter
Claim 8 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: the prior art of record does not teach or suggest a method for controlling temperature of a microfluidic device comprising providing an instrument for performing an assay at a first temperature wherein the instrument comprises a housing and a tray for inserting a microfluidic device into the housing and removing a microfluidic device from the housing wherein the tray comprises a thermal energy source, and is preheated or precooled prior to insertion into the housing.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DWAN A GERIDO whose telephone number is (571)270-3714. The examiner can normally be reached Mon-Fri 10-6.
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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.
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/DWAN A GERIDO/Examiner, Art Unit 1797 /LYLE ALEXANDER/Supervisory Patent Examiner, Art Unit 1797