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 .
Status of Claims
The claim set submitted on 29 JUNE 2023 is acknowledged and considered. In the claim set, Claims 1-18 are presented.
Current pending claims are Claims 1-18 and are considered on the merits below.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 29 JUNE 2023 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The disclosure is objected to because of the following informalities:
There are two periods at the end of [0063].
Appropriate correction is required.
Abstract
The disclosure is objected to because of the following informalities:
Regarding the abstract, the phrase "e.g." and "i.e." renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Appropriate correction is required.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: character 10B. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) 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. 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.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: Figure 13, character 214. 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. 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.
In addition, in Figure 13, there is character 114. Examiner believes this is a misprint and it should be 214.
Claim Objections
Claim 4 is objected to because of the following informalities: the phrase 'yet overlapping with, the ....’ should be ‘yet overlapping with the …’ Appropriate correction is required.
Claim 11 is objected to because of the following informalities: In the instant claim, where it recited ‘the first microfluidic channel, the thermistor having a …” ; should be ‘the first microfluidic channel, the thermistor comprises a …” to properly further define the claim with an appropriate transitional phrase for further defining a limitation. Appropriate correction is required.
Claim 12 is objected to because of the following informalities: In the instant claim, where it recited “ the first microfluidic channel, the resistive heating element having a…” ; should be ‘the first microfluidic channel, the resistive heating comprises a …” to properly further defining the claim with an appropriate transitional phrase for further define a limitation. Appropriate correction is required.
Claim 14 is objected to because of the following informalities: In the last line of Claim 14, the instance of ‘the first microfluid channel’ should be ‘the first microfluidic channel’. Appropriate correction is required. This claim is also rejected under 112(b) below.
Claim 15 is objected to because of the following informalities: In line 3 of the instant claim, the instance of ‘the at least one other microfluidic extends’; should be ‘the at least one other microfluidic channel extends’. Examiner believe the missing word is in error. Appropriate correction is required. The claim has also been rejected under 112(b) below.
Claim 17 objected to because of the following informalities: In the preamble of the instant claim, ‘presence/absence’ should be ‘presence or absence’ to improve clarity of the claims. The ‘presence/absence’ could be interpreted as a ratio. Appropriate correction is required.
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 2, 14, 17 and 18 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 2 recites the limitation "the microfluidic channel". There is insufficient antecedent basis for this limitation in the claim.
It is unclear to the Examiner if the instance of "the microfluidic channel" is referring to "the first microfluidic channel" as claimed in Claim 1 or is there another microfluidic channel to be claimed?
Claim 14 recites the limitation "the first microfluid channel" . There is insufficient antecedent basis for this limitation in the claim.
Claim 15 recites the limitation "the at least one other microfluidic" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claims 17 and 18 are directed to a method of a detecting the presence/absence, but the steps that are positively claim only recite ‘providing’, ‘measuring’ and ‘introducing’. It is unclear to the Examiner how a detecting/detection is occurring. How is even the ‘first sample’ introduced into the device in the ‘measuring step’? Is the device preloaded with a sample so that a first sample does not need to be introduced into the device? Also, is there another step being performed after the ‘introducing’ step? Is there a detection step that should be positively claimed? As the claim is currently presented, there is no detecting/detection step occurring. The body of the claim does not perform what the preamble states it is doing.
Claim 17 recites the limitation "each pair". There is insufficient antecedent basis for this limitation in the claim.
Claim 18 recites the limitation "each pair". There is insufficient antecedent basis for this limitation in the claim.
Claim 18 recites the limitation "the medium" . There is insufficient antecedent basis for this limitation in the claim.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-10 and 13-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-3, 5-8, 13, 14, 16 and 18-19 of U.S. Patent No. 12,270,777 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant invention is directed to a linear microfluidic device and the ‘777 reference discloses a 2D microfluidic structure.
The linear microfluidic device (Claim 1) and the 2D microfluidic structure (Claims 1 and 3) comprises : a first microfluidic channel extending linearly in a first direction and positioned between a first substrate and a second substrate; and at least two electrode portion (electrodes) that are isolated defined as a first group and a second group. Both the instant invention and the 2D microfluidic structure includes a vertical portion/element that extends through each of first and second substrates.
The instant invention positively claims at least one microfluidic sensing cell positioned along the first microfluidic channel while the ‘777 reference is silent in this feature. Claims 13-15 of ‘777 defines a cell. However, the ‘at least one microfluidic sensing cell positioned along the first microfluidic channel’ is broadly claimed and claim language does not define any particular structure associated with the cell so it is interpreted by the Examiner that the ‘cell’ can be any arbitrary location along the first microfluidic channel and therefore it would be obvious to one having ordinary skill in the art before the effective filing date to modify the ‘777 reference to designate “at least one microfluidic sensing cell positioned along the first microfluidic channel” to have a specific location of where mixing/reactions and measuring takes place so that an operator/user is able to focus on a location of where activity is taking place in the device.
Instant Claim 2 is the same as the Claim 2 of ‘777.
Instant Claims 3 and 4 are obvious over Claim 2, 18 and 19 of ‘777.
Instant Claims 5-7 are the same as Claim 5 and 6 of ‘777.
Instant Claim 8 is the same as Claim 8 of ‘777.
Instant Claim 9 is obvious over Claim 8 of ‘777, as the electrically isolated probe electrode of a group is coaxial with a ground electrode as a matter of design choice which would add electromagnetic shielding to the electrodes that are present in the through-via, instant [0052], Column 8 line 45-54 of ‘777.
Instant Claim 10 is taught in Claim 13-14 of ‘777.
Instant Claims 13 is obvious over ‘777. While ‘777 does not claim an inlet and exit port it would be obvious to one having ordinary skill in the art before the effective filing date to modify ‘777 with an inlet and exit port so that samples can be introduced and withdrawn from the device in real time.
Instant Claim 14 is obvious over Claim 16 of ‘777. While ‘777 does not teach a capacitance sensing, it teaches a sensing circuit electrically connected to the structure. It would be obvious to one having ordinary skill in the art before the effective filing date to modify the ‘777 sensing circuit to specifically use capacitance sensing so that dielectric properties in the device can be detected.
Instant Claim 15 of the instant invention is taught by Claim 16 of ‘777.
Instant Claim 16 of the instant invention is taught by Claim 7 of ‘777.
Instant Claim 17 and 18 of the instant invention are obvious over Claims 1, 3 and 16. While ‘777 does not teach a method or the additional steps of measuring, a microfluidic device is provided and the sensing circuit is capable of measuring. The additional step of introducing a second sample is obvious to one having ordinary skill in the art such that in the art detecting / detection of microfluidic device, the act have a sample needed to be added to the device is well-known in the art.
Examiner’s Note
Claims 11 and 12 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.
The claim language in the instant claim are not found or suggested by the prior art of ‘777 in the ODP rejection. The claims at issue are not claimed in ‘777 nor is it found in the disclosure. The ‘777 reference does not even teach or suggest sort of incubation , heating or temperature regulation.
The only pending rejections/objection are the ODP and 112(b) rejections and claim objection to the pending claims. There are objections to the drawings and specification.
If Applicant resolves all the issues above, the Examiner will reconsider and update the search.
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. MCGUINNESS, US Publication No. 2016/0334323 A1 discloses a linear microfluidic device, abstract, comprising: a first microfluidic channel extending linearly in a first direction , Figure 2, [0032]; and at least one microfluidic sensing cell positioned along the first microfluidic channel, Figure 4, the at least one microfluidic sensing cell comprises an upper electrode portion comprising a first group of at least one upper electrically isolated probe electrode and a lower electrode portion comprising a second group of at least one lower electrically isolated probe electrode, Figure 1, electrodes 34 and 34’, [0031], wherein the at least one upper electrically isolated probe electrode of the first group has a vertical portion, [0068], and the at least one lower electrically isolated probe electrode of the second group has a vertical portion, [0068].
MCGUINNESS however does not teach or suggest the claim language of :a first microfluidic channel extending linearly in a first direction and positioned between a first substrate and a second substrate; and wherein the at least one upper electrically isolated probe electrode of the first group has a vertical portion that extends entirely through the first substrate and the at least one lower electrically isolated probe electrode of the second group has a vertical portion that extends entirely through the second substrate.
In addition, EDWARDS to US Publication No. 2019/0329255 A1 discloses a sensor using electrophoresis may include a microfluidic channel and electrodes on opposite sides of the microfluidic channel to generate an electric field across, or normal to, the channel. The electric field may be used to drive charged particles of material, particularly material suspended in fluid in the microfluidic channel, toward or away from the one of the electrodes. The electric field may be modulated to allow material to continue flowing through the microfluidic channel, to remove non-target material, or to measure another target material, abstract, Figure 3, [0009].
While it is known in the art of multilayered microfluidic devices with a channel disposed between two substrates, the limitation of wherein the at least one upper electrically isolated probe electrode of the first group has a vertical portion that extends entirely through the first substrate and the at least one lower electrically isolated probe electrode of the second group has a vertical portion that extends entirely through the second substrate is not found or suggested in the prior art or upon further searching by the Examiner.
Besides the art used in the ODP. The MCGUINNESS only teaches electrodes along the channel and spaced apart from each other. The reference is silent in regards to the language of the vertical portion that extends entirely through the substrates as seen in instant Figure 1A and 1B.
There is not obvious motivation for an ordinary skilled individual in the art to combine some and/or all the feature of prior art to achieve these structure feature. The structural modification of the components would require substantial modifications of the measurement and configuration to achieve these features.
The claims directed towards the methods include verbatim the same structure features of using the device. There are 112(b) rejections of the method claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINE T MUI whose telephone number is (571)270-3243. The examiner can normally be reached M-Th 5:30 -15:30 EST.
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CTM
/CHRISTINE T MUI/Primary Examiner, Art Unit 1797