Prosecution Insights
Last updated: October 25, 2026
Application No. 18/615,677

Microfluidic Assay Assemblies and Methods of Manufacture

Non-Final OA §112§DOUBLEPATENT
Filed
Mar 25, 2024
Priority
Nov 23, 2009 — provisional 61/263,572 +12 more
Examiner
SMITH JR., JIMMY R
Art Unit
1700
Tech Center
1700 — Chemical & Materials Engineering
Assignee
Cyvek Inc.
OA Round
2 (Non-Final)
65%
Grant Probability
Favorable
2-3
OA Rounds
3m
Est. Remaining
99%
With Interview

Examiner Intelligence

Grants 65% — above average
65%
Career Allowance Rate
307 granted / 471 resolved
At TC average
Strong +42% interview lift
Without
With
+42.4%
Interview Lift
resolved cases with interview
Typical timeline
2y 10m
Avg Prosecution
26 currently pending
Career history
506
Total Applications
across all art units

Statute-Specific Performance

§101
0.6%
-39.4% vs TC avg
§103
44.8%
+4.8% vs TC avg
§102
15.2%
-24.8% vs TC avg
§112
36.3%
-3.7% vs TC avg
Black line = Tech Center average estimate • Based on career data from 471 resolved cases

Office Action

§112 §DOUBLEPATENT
The arguments and amendments submitted 10/03/2025 have been considered. In light of amendments made, the statutory double patenting rejection of claims 1-5 and the 112, second paragraph, rejection of claim 6 in the previous office action are hereby withdrawn. The merits of the claims are discussed below. Notice of Pre-AIA or AIA Status The present application is being examined under the pre-AIA first to invent provisions. Claim Objections The following claim(s) are objected to because of these informalities: In claim 7, line 12, “pnueumatic” should read “pneumatic”. In claim 8, line 1, “make and break protocol” should read "make-and-break-contact protocol". Appropriate correction is required. Claim Rejections - 35 USC § 112 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 7-12 are rejected under 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 applicant regards as the invention. Claim 7, lines 6-7 recite "the fluidic channel" in two locations. It is unclear which of the plurality of fluidic channels is being referenced. Dependent claims fall herewith. Claim 7, line 7 recites "a floor of the fluidic channel". It is unclear whether this floor is the same or different than the one recited earlier in the claim. Dependent claims fall herewith. Claim 7, lines 8-9 recite "the contacting faces of the actuator diaphragm and actuator seat", along with a similar recitation in claim 8, line 2. This term does not have antecedent basis. Furthermore, it is unclear whether this term instead refers to the at least one contact position of the actuator diaphragm and actuator seat. Dependent claims fall herewith. Claim 12, line 2 recites "the diaphragm portion". This term does not have antecedent basis and it is unclear whether this element is the same or different than the actuator diaphragm recited in the parent claim. Double Patenting 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 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 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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp. Claims 1 and 2 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 15 of US Patent 11,938,710 in view of Hayenga (US Patent 6,431,212). Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons: Regarding claims 1 and 2, claim 15 of the ‘710 patent recites each of the instant features or a corresponding feature of narrower scope, with one exception as discussed below, and therefore anticipates the features of these instant claims except for the feature described below. The ‘710 patent does not teach that the microfluidics actuator is within a fluidic channel. However, Hayenga teaches that locating a microfluidics actuator within a fluidic channel provides for control of fluids passing through the channel and is a useful component in inexpensive microscale devices for performing analytical testing (abstract, col. 1, lines 14-35, Figs. 1, 2, and 6). Thus, in view of Hayenga’s teachings, it would have been obvious to one of ordinary skill in the art to modify the method of the ‘710 patent to use a microfluidics actuator within a fluidic channel as taught by Hayenga to predictably obtain the fluid control functionality and utility in analytical testing applications described by Hayenga as cited above. Allowable Subject Matter Claims 3-6 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. Claim 7 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph and with correction for the objection to the claim, set forth in this Office action. Claims 8-12 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 for claim 8, correction for the claim objection). Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to JIM R SMITH whose telephone number is (303)297-4318. The examiner can normally be reached Mon-Fri. 9-6 MST. 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, Phillip Tucker can be reached on 571-272-1095. 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. /J.R.S/Examiner, Art Unit 1745 /PHILIP C TUCKER/Supervisory Patent Examiner, Art Unit 1745
Read full office action

Prosecution Timeline

Mar 25, 2024
Application Filed
Apr 10, 2025
Non-Final Rejection mailed — §112, §DOUBLEPATENT
Oct 03, 2025
Response Filed
Sep 22, 2026
Non-Final Rejection mailed — §112, §DOUBLEPATENT (current)

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Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

2-3
Expected OA Rounds
65%
Grant Probability
99%
With Interview (+42.4%)
2y 10m (~3m remaining)
Median Time to Grant
Moderate
PTA Risk
Based on 471 resolved cases by this examiner. Grant probability derived from career allowance rate.

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