Prosecution Insights
Last updated: October 25, 2026
Application No. 18/809,744

FLUID MIXING DEVICE AND FLUID DELIVERY TUBE SET INCLUDING SAME

Non-Final OA §112§DOUBLEPATENT
Filed
Aug 20, 2024
Priority
Feb 28, 2020 — provisional 62/982,995 +3 more
Examiner
FREDRICKSON, COURTNEY B
Art Unit
3783
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Bayer HealthCare LLC
OA Round
1 (Non-Final)
75%
Grant Probability
Favorable
1-2
OA Rounds
11m
Est. Remaining
99%
With Interview

Examiner Intelligence

Grants 75% — above average
75%
Career Allowance Rate
310 granted / 411 resolved
+5.4% vs TC avg
Strong +30% interview lift
Without
With
+29.6%
Interview Lift
resolved cases with interview
Typical timeline
3y 1m
Avg Prosecution
46 currently pending
Career history
464
Total Applications
across all art units

Statute-Specific Performance

§101
1.6%
-38.4% vs TC avg
§103
41.0%
+1.0% vs TC avg
§102
19.3%
-20.7% vs TC avg
§112
31.0%
-9.0% vs TC avg
Black line = Tech Center average estimate • Based on career data from 411 resolved cases

Office Action

§112 §DOUBLEPATENT
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 . Information Disclosure Statement The information disclosure statement (IDS) submitted is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. Claim Objections Claim 1 is objected to because of the following informalities: Regarding claim 1, the claims should be amended to recite “a first/second injection fluid” in lines 12 and 15 to provide antecedent basis for the claim terminology. 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 7, 11, and 12-19 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 7 recites the limitation "the first inlet port" and “the second inlet port”. There is insufficient antecedent basis for this limitation in the claim. It is unclear if these limitations should be “a first/second inlet port” or if the claim should be dependent on claim 4 instead. For examination purposes, the first interpretation was used. Regarding claims 11, 12, and 19, the claims are directed towards first and second different directions being angled toward each other with a 0-90 degree angle. It is unclear if this angle is the angle formed by the different directions. If so, it is unclear how the different directions can form a 0 degree angle and still be angled toward each other as it would seem that a 0 degree angle would indicate that the two directions are parallel to each other and would not be angled toward each other. Claims 13-18 are also rejected by virtue of being dependent on claim 12. 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 1-4 and 7-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 6, 7, and 13-15 of U.S. Patent No. 12070568 in view of Stokes (US 20120123257) (see table below). Regarding claim 1, claim 1 of the issued patent claims all of the claimed limitations set forth in instant claim 1 except that issued claim 1 does not claim an injector head comprising a first syringe port and a second syringe port, and a first reciprocally driven piston and a second reciprocally driven piston; a first syringe connected to the first syringe port, wherein the first syringe comprises a first plunger releasably connectable to the first reciprocally driven piston, and a first port at a distal end of the first syringe; a second syringe connected to the second syringe port, wherein the second syringe comprises a second plunger releasably connectable to the second reciprocally driven piston, and a second port at a distal end of the second syringe. Stokes teaches a fluid mixing device comprising an injector head (injector 20 in fig. 1) comprising a first syringe port and a second syringe port (fig. 1 shows the distal end receiving a first and second syringe at the distal end of injector 20; paragraph 99), and a first reciprocally driven piston (piston element 60 in fig. 44A) and a second reciprocally driven piston (other piston element 60 in fig. 44A); a first syringe connected to the first syringe port (syringe 1120 in fig. 16), wherein the first syringe comprises a first plunger releasably connectable to the first reciprocally driven piston (plunger 1300 in fig. 16), and a first port at a distal end of the first syringe (discharge outlet 1130 in fig. 8); a second syringe connected to the second syringe port (other syringe 1122 in fig. 16), wherein the second syringe comprises a second plunger releasably connectable to the second reciprocally driven piston (other plunger 1300 in fig. 16), and a second port at a distal end of the second syringe (other discharge outlet 1130 in fig. 8). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the issued claim to claim the limitations above drawn to the injection assembly as Stokes teaches that these elements provide the structure necessary to inject multiple fluids to a patient in an automated fashion (paragraph 2). Instant Claims '568 Claims Teaching 1 1 See discussion above 2 2 3 3 4 7 7 6 8 13 9 14 10 15 Claims 5 and 6 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 7 of U.S. Patent No. 12070568 in view of Stokes and in further view of Harding (US 3868967). Regarding claims 5 and 6, modified claim 1 of the issued patent claims all of the claimed limitations set forth in instant claims 1 and 4, as discussed above, but does not claim at least one of the first redirecting surface and the second redirecting surface each have a substantially concave-shaped surface facing the first inlet port and a second inlet port, respectively [claim 5] and the third redirecting surface has a substantially concave-shaped surface facing the outlet port [claim 6]. Harding is directed towards a mixing device in which a first and second redirecting surface (see below) each have a substantially concave shape facing a first and second inlet port respectively and a third redirecting surface has a substantially concave-shaped surface facing the outlet port (see below). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the issued claim to have the claimed features as Harding teaches that this configuration provides for turbulent flow within the mixing chamber (fig. 2). PNG media_image1.png 388 468 media_image1.png Greyscale Claims 11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12070568 in view of Stokes and in view of Schriver (US 20140261713). Regarding claim 11, modified claim 1 of the issued patent claims all of the claimed limitations set forth in instant claim 11 except that the first different direction and the second different direction are angled toward each other with a 0° to 90° angle so that the first fluid and the second fluid directly impact each other in the mixing chamber to turbulently mix. Schriver teaches a mixing device (fig. 26) comprising first and second different directions (direction of fluid flow through tubes 233k and 235k in fig. 26) which form an acute angle with each other (fig. 26) so that the first fluid and the second fluid directly impact each other in the mixing chamber to turbulently mix (paragraph 138). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the issued claim to further claim that the first different direction and the second different direction are angled toward each other with a 0° to 90° angle so that the first fluid and the second fluid directly impact each other in the mixing chamber to turbulently mix, as taught by Schriver, as Schriver teaches an acute angle ensures that the two fluids directly contact each other to mix (paragraph 138). Claims 12-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 13, and 18 of U.S. Patent No. 12070568 in view of Schriver (see table below). Regarding claims 12 and 19, claim 1 of the issued patent claims all of the claimed limitations set forth in claims 12 and 19 except that issued claim 1 does not claim wherein the first different direction and the second different direction are angled toward each other with a 0° to 90° angle so that the first fluid and the second fluid directly impact each other in the mixing chamber to turbulently mix. Schriver teaches a mixing device (fig. 26) comprising first and second different directions (direction of fluid flow through tubes 233k and 235k in fig. 26) which form an acute angle with each other (fig. 26) so that the first fluid and the second fluid directly impact each other in the mixing chamber to turbulently mix (paragraph 138). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the issued claim to further claim that the first different direction and the second different direction are angled toward each other with a 0° to 90° angle so that the first fluid and the second fluid directly impact each other in the mixing chamber to turbulently mix, as taught by Schriver, as Schriver teaches an acute angle ensures that the two fluids directly contact each other to mix (paragraph 138). Instant Claims '568 Claims Teaching 12 1 see discussion above 13 1 14 1 15 1 16 1 17 13 18 18 19 1 see discussion above Claims 12-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 11712552 in view of Schriver (see table below). Regarding claims 12 and 19, claim 1 of the issued patent claims all of the claimed limitations set forth in claims 12 and 19 except that issued claim 1 does not claim wherein the first different direction and the second different direction are angled toward each other with a 0° to 90° angle so that the first fluid and the second fluid directly impact each other in the mixing chamber to turbulently mix. Schriver teaches a mixing device (fig. 26) comprising first and second different directions (direction of fluid flow through tubes 233k and 235k in fig. 26) which form an acute angle with each other (fig. 26) so that the first fluid and the second fluid directly impact each other in the mixing chamber to turbulently mix (paragraph 138). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the issued claim to further claim that the first different direction and the second different direction are angled toward each other with a 0° to 90° angle so that the first fluid and the second fluid directly impact each other in the mixing chamber to turbulently mix, as taught by Schriver, as Schriver teaches an acute angle ensures that the two fluids directly contact each other to mix (paragraph 138). Instant Claims '552 Claims Teaching 12 1 See discussion above 13 1 14 8 15 4 16 5 17 11 18 15 19 1 See discussion above Allowable Subject Matter Claims 1-10 would be allowable if rewritten or amended to overcome the double patenting rejection(s) set forth in this Office action or with the filing of a terminal disclaimer. Claims 12-19 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, set forth in this Office action and with the filing of a terminal disclaimer. The following is a statement of reasons for the indication of allowable subject matter: Regarding claims 1, 12, and 19, the closest prior art is Harding which comprises a fluid mixing device having a first and second fluid inlet (see below), first and second redirecting surfaces (see below), a mixing chamber in fluid communication with the first and second inlets (chamber 16 in fig. 2) and comprising a third redirecting surface (see below), and an outlet (see below). Harding further discloses the third redirecting surface is positioned proximally to the outlet port and the first/second redirecting surfaces (see below). However, as seen below, the first and second redirecting surfaces are positioned within the mixing chamber (16) so that it is the examiner’s opinion that the first/second redirecting surfaces cannot reasonably be considered to be part of the first and second fluid inlet, respectively, as required by the claim . The examiner further notes that Harding teaches first and second redirecting surfaces within the first and second fluid inlets in the form of baffles (baffles 37 and 43 in fig. 2); however, these surfaces are positioned proximally to the third redirecting surface and not distally to the third redirecting surface, as required by the claim. PNG media_image1.png 388 468 media_image1.png Greyscale Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to COURTNEY FREDRICKSON whose telephone number is (571)270-7481. The examiner can normally be reached Monday-Friday (9 AM - 5 PM EST). 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, BHISMA MEHTA can be reached at 571-272-3383. 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. /COURTNEY FREDRICKSON/Primary Examiner, Art Unit 3783
Read full office action

Prosecution Timeline

Aug 20, 2024
Application Filed
Oct 05, 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

1-2
Expected OA Rounds
75%
Grant Probability
99%
With Interview (+29.6%)
3y 1m (~11m remaining)
Median Time to Grant
Low
PTA Risk
Based on 411 resolved cases by this examiner. Grant probability derived from career allowance rate.

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