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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on September 2, 2026 has been entered.
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.
Claim(s) 1, 6-7, 9-10, 14-16, 20-21, 24-26, 30-32, 35, 38, 40 and 51 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sharkey et al (US 2020/0103398, submitted in the IDS filed on October 4, 2023) in view of Daf (US 2013/0064736, submitted in the IDS filed on April 14, 2026).
With regards to claim 1, Sharkey et al teach of a system for reconstituting a dried reagent composition used in an assay of one or more analytes in a biological sample. The system 10 comprises a liquid container 12 in the form of a vial or test tube. The liquid container 12 has an open end at the top and a bottom separated by a wall therebetween (see Figure 1 in Sharkey et al), wherein an inner surface of the wall comprises multiple dried reagent compositions 14, 16 and 18 that are configured to dissociate from the inner surface upon contact with a liquid sample (see paragraphs 0067-0068 in Sharkey et al). Sharkey et al teach that the dried reagent compositions located inside of the liquid container are reconstituted by positioning a volume of liquid in the container in a manner that the liquid contacts the dried reagent compositions. Sharkey et al teach that the contents of the liquid container after positioning the volume of reconstituting liquid inside the container are mixed using any convenient protocol, such as an agitator, a rocker, a static mixer, a rotator, a blender, and other mixers or agitating means. See Figure 1 and paragraphs 0017, 0019, 0025, 0028, 0065, 0067-0072 in Sharkey et al.
Sharkey et al fail to teach that the system for reconstituting a dried reagent composition also comprises a solid volume displacer configured to be positioned inside of the liquid container 12 to occupy more than 50% of the liquid container volume below the top of the liquid container, wherein the solid volume displacer is substantially inert with respect to the liquid sample and the reagent composition.
Daf teaches of a system comprising a solid volume displacer in the form of a plunger 10 that is configured to be inserted into a liquid container 20 for mixing a biological sample with a reagent in the container 20. The plunger 10 is substantially inert with respect to the biological sample and the reagent located in the liquid container 20. The plunger 10 comprises a first end portion having an opening 16, a second end portion opposite the first end portion, and a wall containing slots 14 located between the first and second end portions. The first end portion having an opening 16 comprises a flange 18 that allows the first end portion to be located outside of the container 20 when the body of the plunger 10 and the second end portion are positioned inside of the liquid container 20. Daf also teaches that the plunger is hollow (see paragraph 0020 in Daf where it states that “The plunger 10 has a cylindrical shape with a hollow interior”). The solid volume displacer 10 is configured to be positioned inside the liquid container 20 to occupy more than 50% of the liquid container volume below the top of the liquid container, as depicted in Figures 1, 3 and 4 of Daf. Daf teaches that when the plunger is moved downward inside of the container 20, a portion of a fluid comprising a biological sample and a reagent located inside of the container 20 will move upward into the gap between the outer surface of the plunger and the container 20 so as mix the biological sample with the reagent. The plunger 10 is moved up and down reciprocally in the container 20 so as agitate and mix the biological sample and the reagent. Another portion of the fluid will flow into the hollow interior of the plunger 10 through the slots 14 and an aperture 12 located at the second end portion of the plunger 10. See Figures 3 and 4, and paragraphs 0017-0020 in Daf.
Based upon the combination of Sharkey et al and Daf, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a solid volume displacer in the system for reconstituting a dried reagent composition taught by Sharkey et al which is configured to be positioned inside of the liquid container 12 to occupy more than 50% of the liquid container volume below the top of the liquid container and which is substantially inert with respect to a liquid sample added to the container and the dried reagent composition because Sharkey et al teach that the system may include some type of agitator device for mixing a liquid sample added to the container 12 with the dried reagent compositions 14, 16 and 18 located on the inner surface of the wall of the container 12, and Daf teaches that one known type of agitator device that provides enhanced mixing of a liquid sample and a reagent added to a liquid container tube comprises an inert solid volume displacer configured to occupy more than 50% of the liquid container volume below the top of the liquid container, and that this solid volume displacer provides enhanced mixing by moving the solid volume displacer up and down reciprocally in the container so as agitate and mix the liquid sample and the reagent.
With regards to claims 6-7 and 9, Sharkey et al teach that the dried reagent compositions 14, 16 and 18 on the inner wall of the liquid container 12 comprise a dye, wherein the dye can be a conjugated polymer. See paragraphs 0025-0028, 0041 and 0043 in Sharkey et al.
With regards to claim 10, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a volume of liquid in the container taught by the combination of Sharkey et al and Daf that is equal to or greater than the volume of the liquid container below the top of the dried reagent compositions 14, 16 and 18 that the solid volume displacer taught by Daf is not configured to occupy since this would allow a minimum volume of liquid to be added to the container for mixing with the dried reagents while also allowing the liquid to be displaced and rise in the container for reconstitution of the dried reagents when the solid volume displacer is inserted into the lower portion of the container.
With regards to claims 14-16, Sharkey et al teach that the inner surface of the wall of the liquid container 12 comprises two or more or six or more distinctly positioned dried reagent compositions located at separate locations on the inner surface. See Figure 1 and paragraphs 0025-0028 in Sharkey et al.
With regards to claim 20, both Sharkey et al and Daf teach that the liquid container is a tube or vial. See Figure 1 in Sharkey et al and Figures 3-4 in Daf.
With regards to claim 21, Daf teaches that the solid volume displacer 10 is configured as a pestle since the second end portion of the solid volume displacer 10 opposite the opening 16 has the configuration of a common pestle. See Figures 3-4 in Daf.
With regards to claims 24-25, Daf teaches that the solid volume displacer 10 has a first end portion containing an opening 16, a second end portion opposite the first end portion, and a body containing slots 14 therebetween, wherein the second end portion and the body are configured to be positioned inside of the liquid container 20, and wherein the body is configured as a solid cylinder. See Figures 3-4 in Daf which depict the body of the displacer 10 as having a cylindrical shape.
With regards to claim 26, Daf teaches that the body of the solid volume displacer 10 comprises an outside surface that is concentric to the inner surface of the wall of the liquid container 20. See Figure 4 in Daf which depicts the body of the displacer 10 as having a cylindrical shape that is concentric to the inner surface of the wall of the liquid container 20.
With regards to claim 30, the combination of Sharkey et al and Daf fails to teach that the outside surface of the body of the solid volume displacer and the wall of the liquid container are tapered. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the outside surface of the body of the solid volume displacer and the wall of the liquid container of the system taught by the combination of Sharkey et al and Daf as tapered surfaces because Daf suggests that a conventional plunger used for agitating a sample and a reagent in a tube can be a tapered, solid cylinder (see paragraph 0003 in Daf), and providing tapered surfaces for the solid volume displacer and the wall of the liquid container would help facilitate the movement of liquid added to the container to the bottom of the container where the second end of the solid volume displacer is located to contact and provide sufficient mixing of the liquid upwards into the container.
With regards to claim 31, Daf teaches that the first end of the solid volume displacer 10 containing the opening 16 is configured to be positioned outside of the liquid container 20 when the body and the second end of the displacer 10 are positioned inside the liquid container 20. See Figures 3-5 in Daf.
With regards to claim 32, Daf teaches that the first end of the solid volume displacer 10 containing the opening 16 comprises a flange 18. See Figures 3-5 in Daf.
With regards to claim 35, the combination of Sharkey et al and Daf fails to teach that the solid volume displacer 10 in the system further comprises a ring of filer media positioned around the outside of the body near the first end portion. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the first end portion of the solid volume displacer 10 taught by Daf and included in the reconstitution system taught by Sharkey et al with a ring of filter media positioned around the outside of the body near the first end portion because such a filter media would prevent liquid splashing out of the container when the displacer is inserted into the container and reciprocally moved up and down to mix the liquid sample with the dried ligand reagents on the body of the displacer.
With regards to claim 38, Daf teaches that the solid volume displacer 10 is hollow. See paragraph 0020 in Daf where it states that “The plunger 10 has a cylindrical shape with a hollow interior”.
With regards to claim 40, Daf teaches that the second end portion of the solid volume displacer 10 is rounded and concentric to the bottom of the liquid container 30. See Figures 3-4 in Daf.
With regards to claim 51, Sharkey et al teach that the liquid container 12 can comprise a removable cap configured to seal the container 12. See paragraphs 0023 and 0070 in Sharkey et al.
Response to Arguments
Applicant's arguments filed September 2, 2026 have been fully considered but they are not persuasive.
The previous rejections of the claims made under 35 USC 112(b) in the last Office action mailed on July 1, 2026 have been withdrawn in view of the amendments made to the claims. The previous rejections of the claims made under 35 USC 103 as being obvious over Sharkey et al in view of Kilthau, or over Sharkey et al in view of Kilthau and further in view of Daf, have also been withdrawn in view of the amendments made to the claims and Applicant’s persuasive argument stating that the combination of Sharkey et al and Kilthau fails to teach or fairly suggest a solid volume displacer configured to be positioned inside of a liquid container that is substantially inert with respect to a liquid sample and a reagent composition contained within the liquid container, as is now recited in claim 1. However, in light of the amendments made to the claims, the amended claims are now rejected under 35 USC 103 as being obvious over Sharkey et al in view of Daf for the reasons set forth above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAUREEN M WALLENHORST whose telephone number is (571)272-1266. The examiner can normally be reached on Monday-Thursday from 6:30 AM to 4:30 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lyle Alexander, can be reached at telephone number 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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/MAUREEN WALLENHORST/Primary Examiner, Art Unit 1797 September 24, 2026
