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 9 and 40 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 9 is indefinite since it depends from canceled claim 8. Claim 9 should be amended to depend from claim 7 in order to give the dye recited in claim 9 proper antecedent basis since claim 7 positively recites that the dried reagent composition comprises a dye.
On lines 1-2 of claim 40, the phrase “the second end of the solid volume displacer” lacks antecedent basis since claim 40 depends from claim 1, and claim 1 does not positively recite a second end of the solid volume displacer. Claim 40 should be amended to depend from claim 31 since claim 40 was previously dependent on claim 31 in the set of claims filed on August 8, 2023.
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, 35, 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 Kilthau (US 3,464,798, cited in the last Office action mailed on March 4, 2026 and also 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. 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.
Kilthau teaches of a solid volume displacer 10 for displacing a small amount of a liquid in a container or tube 30. The solid volume displacer 10 comprises a first end 26, a second end 22 and a body 12 located around a shaft 20 of the displacer 10 between the first and second ends. A flange 24 is located near the first end 26 of the displacer for placing the displacer 10 at a desired height within the container 30. When the solid volume displacer is inserted into a tube 30 containing a small amount of a liquid, the end portion 22 of the displacer forces the liquid up above the end portion 22 to occupy a space between the body 12 and the inner sides of the tube 30. The solid volume displacer 10 is configured to be positioned inside the liquid container 30 to occupy more than 50% of the liquid container volume below the top of the liquid container, as depicted in Figure 3 of Kilthau. Kilthau teaches that the body 12 of the solid volume displacer 10 has an active chemical 18 located thereon which mixes with a fluid in the tube 30 when the solid volume displacer 10 is inserted into more than 50% of the volume inside the tube 30 and forces the fluid to rise in the tube from a level indicated as A-A in Figure 3 to a level B-B shown in Figure 3 of Kilthau. See Figures 1-3, lines 42-72 in column 2, and lines 1-9 and lines 65-71 in column 3 of Kilthau.
Based upon the combination of Sharkey et al and Kilthau, 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 because Sharkey et al teach that the system may include some type of agitator device for mixing a liquid 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 Kilthau teaches that one known type of agitator device that provides enhanced mixing of a liquid added to a liquid container tube with dried reagents comprises a 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 displacing the liquid upward to contact and mix with the dried reagents.
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 Kilthau 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 Kilthau 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 Kilthau teach that the liquid container is a tube or vial. See Figure 1 in Sharkey et al and Figure 3 in Kilthau.
With regards to claim 21, Kilthau teaches that the solid volume displacer 10 is configured as a pestle since the end portion 22 of the solid volume displacer 10 has the configuration of a common pestle. See Figure 2 in Kilthau.
With regards to claims 24-25, Kilthau teaches that the solid volume displacer 10 has a first or proximal end portion 26, a second or distal end portion 22, and an intermediate shaft 20 surrounded by a body 12 of material therebetween, wherein the second end 22 and the body 12 are configured to be positioned inside of the liquid container 30, and wherein the body 12 located on the shaft 20 is configured as a solid cylinder. See Figures 1-3 in Kilthau which depict the body 12 of the displacer 10 as having a cylindrical shape with dried chemical reagents adhered thereto.
With regards to claim 26, Kilthau teaches that the body 12 of the solid volume displacer 10 comprises an outside surface that is concentric to the inner surface of the wall of the liquid container 30. See Figure 3 in Kilthau which depicts the body 12 of the displacer 10 as having a cylindrical shape that is concentric to the inner surface of the wall of the liquid container 30.
With regards to claim 30, the combination of Sharkey et al and Kilthau 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 Kilthau as tapered surfaces because doing so 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 35, the combination of Sharkey et al and Kilthau 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 26. 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 26 of the solid volume displacer 10 taught by Kilthau and included in the reconstitution system taught by Sharkey et al with a ring of filter media positioned around the outside of the body 12 near the first end portion 26 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 12 of the displacer.
With regards to claim 40, Kilthau teaches that the second end portion 22 of the solid volume displacer 10 is rounded and concentric to the bottom of the liquid container 30. See Figures 2 and 3 in Kilthau.
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.
Claim(s) 31-32 and 38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sharkey et al in view of Kilthau as applied to claims 1, 6-7, 9-10, 14-16, 20-21, 24-26, 30, 35, 40 and 51 above, and further in view of Daf (US 2013/0064736, submitted in the IDS filed on April 14, 2026). For a teaching of Sharkey et al and Kilthau, see previous paragraphs in this Office action.
With regards to claims 31-32 and 38, the combination taught by Sharkey et al and Kilthau fails to teach that the first end portion 26 solid volume displacer comprises a flange and is configured to be positioned outside of the liquid container 30 when the body 12 and the second end portion 22 are positioned inside the container 30, and fails to teach that the solid volume displacer 10 is hollow.
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 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”). Daf teaches that when the plunger is moved downward inside of the container 20, a portion of a fluid located inside of the container 20 will move upward into the gap between the outer surface of the plunger and the container 20. 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.
With regards to claims 31-32 and based upon the combination of Sharkey et al, Kilthau 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 provide a flange on the first end 26 of the solid volume displacer 10 taught by Kilthau in the system so that the first end of the displacer 10 is configured to be positioned outside of the liquid container when the body and the second end of the displacer 10 are positioned inside of the liquid container because Daf teaches that such a flange on an upper end of a solid volume displacer/plunger is advantageous since it allows a user to easily grip the upper end of the displacer/plunger when the displacer/plunger is located inside of a liquid container for easy removal of the displacer/plunger from the container. With regards to claim 38, and based upon the combination of Sharkey et al, Kilthau 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 configure the solid volume displacer taught by Kilthau in the system as a hollow displacer because Daf teaches that a hollow solid volume displacer or plunger allows for a fluid in a liquid container into which the displacer is inserted to be additionally mixed inside of the displacer, and a hollow displacer would require less material during manufacture.
Response to Arguments
Applicant's arguments filed May 21, 2026 have been fully considered but they are not persuasive.
The previous objection to the disclosure made in the last Office action mailed on March 4, 2026 has been withdrawn in view of the amendments made to the specification. The previous rejections of the claims made under 35 USC 112(b) have also been withdrawn in view of the amendments made to the claims. However, some of the amended claims have been newly rejected under 35 USC 112(b) for the reasons set forth above and as necessitated by the amendments made to the claims.
Applicant argues the previous rejections of the claims under 35 USC 103 as being obvious over Sharkey et al (US 2020/0103398) in view of Harris et al (US 5,578,446), or obvious over Sharkey et al (US 2020/0103398) in view of Harris et al (US 5,578,446) and further in view of Kilthau (US 3,464,798) by stating that the combined teachings of Sharkey et al and Harris et al do not teach of “a solid volume displacer configured to be positioned inside of the liquid container to occupy more than 50% of the liquid container volume below the top of the liquid container” as now recited in independent claim 1 since dipstick taught by Harris et al does not occupy more than 50% of the liquid container volume below the top of the liquid container, as depicted in Figure 2 of Harris et al. This argument is persuasive, and therefore, the amended claims are no longer rejected under 35 USC 103 as being obvious over Sharkey et al (US 2020/0103398) in view of Harris et al (US 5,578,446), or obvious over Sharkey et al (US 2020/0103398) in view of Harris et al (US 5,578,446) and further in view of Kilthau (US 3,464,798). However, the amended claims are now rejected under 35 USC 103 as being obvious over Sharkey et al in view of Kilthau, or under 35 USC 103 as being obvious over Sharkey et al in view of Kilthau and further in view of Daf for the reasons set forth above and as necessitated by the amendments made to the claims. As clearly depicted in Figure 3 of Kilthau, the solid volume displacer 10 is configured to be positioned inside the liquid container 30 to occupy more than 50% of the liquid container volume below the top of the liquid container. 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 because Sharkey et al teach that the system may include some type of agitator device for mixing a liquid 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 Kilthau teaches that one known type of agitator device that provides enhanced mixing of a liquid added to a liquid container tube with dried reagents comprises a 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 displacing the liquid upward to contact and mix with the dried reagents.
This Office action is being made final since all of the new rejections included herein are necessitated by the amendments made to the claims.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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.
Information regarding the status of an application may be obtained from Patent Center. Status information for published applications may be obtained from Patent Center. Status information for unpublished applications is available through Patent Center to authorized users only. Should you have questions about access to the USPTO patent electronic filing system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
Examiner interviews are available via a variety of formats. See MPEP § 713.01. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) Form at https://www.uspto.gov/InterviewPractice.
/MAUREEN WALLENHORST/Primary Examiner, Art Unit 1797 June 25, 2026
Prosecution Insights