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 .
Specification
The disclosure is objected to because of the following informalities: On page 41, line 24 of the specification, the phrase “U.S. Patent Application No. 16/725,756, filed on December 23, 2019” should be changed to –U.S. Patent no. 11,085,868—since this application has now been patented.
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 1, 6-7, 9-10, 14-16, 20-21, 24-26, 30-32, 35, 38, 40 and 51 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.
On lines 4-5 of claim 1, the phrase “a solid volume displacer configured to be positioned inside of the liquid container to occupy a majority of the liquid container volume below the top of the dried reagent composition” is indefinite since it is not clear what constitutes being a “majority” in this phrase. Does the majority of the liquid container volume below the top of the dried reagent composition mean 99%, 90%, 80%, 70%, 60%, 50%, etc. of this liquid container volume, or some other amount of the liquid container volume?
Claim 51 is indefinite since it is not clear where the seal is located in the liquid container. Is the seal located over the open end of the liquid container?
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, 30-31, 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 Harris et al (US 5,578,446).
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 a majority of the liquid container volume below the top of the dried reagent compositions 14, 16 and 18.
Harris et al teach of a solid volume displacer 2 in the form of a dipstick that is configured to be placed inside of a liquid container 3 to occupy a portion of the liquid container volume and facilitate a mixing and a turbulent flow of a liquid placed into the container. The solid volume displacer 2 comprises an elongated member 4 that include a first or proximal end portion 6, a second or distal end portion 8, and an intermediate or carrier portion 10 therebetween. The first end portion 6 includes a gripping member or section 12, while the second end portion 8 forms a fluid displacing member 18. The intermediate portion carries one or more reactive ligands on a solid support 10 for reacting and binding with specific analytes in a liquid sample added to the container 3. The fluid displacing member 18 at the end of the second end portion 8 of the solid volume displacer 2 acts to displace a liquid sample added to the container 3 up from the closed end of the container 3 to immerse the solid support 10 containing the reactive ligands in the liquid sample. The displacing member 18 has a configuration and is of sufficient volume to essentially fill a recess 28 at the base of the container 3 so that is displaces essentially all of the liquid sample at the bottom 30 of the container 3. The configuration of the outer surface of the lower portion of member 18 substantially conforms with the configuration of the inside side wall 26 and the inner bottom wall 27 at the bottom region of the container 3. Harris et al teach that the solid volume displacer 2 provides the advantages of adding a lower liquid sample volume to the liquid container 3 for reacting with the solid-phase, dried ligands on the solid support 10 of the displacer, and of providing improved mixing of the liquid sample added to the container 3 when the solid volume displacer is vertically reciprocated in and out of the liquid sample in the container 3. The displacer 2 is immersed sufficiently deep into the liquid sample added to the container 3 such that the displacer 2 displaces the liquid upward and causes sufficient immersion and mixing of the liquid sample with the dried ligands on the solid support 10. The solid volume displacer 2 produces swirling eddy currents in the liquid container 3 which results in enhanced mixing of the liquid sample with the ligand reagents on the solid support 10. See Figures 1-2, the abstract, lines 60-67 in column 1, lines 1-35 in column 2, lines 55-67 in column 3, lines 14-41 in column 5, and lines 6-30 in column 6 of Harris et al.
Based upon the combination of Sharkey et al and Harris et al, 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 a majority of the liquid container volume below the top of the dried reagent compositions 14, 16 and 18 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 Harris et al teach that one known type of agitator device that provides enhanced mixing of a liquid added to a liquid container tube comprises a solid volume displacer configured to occupy a majority of the liquid container volume located below a location where dried reagents disposed on a solid support surface of the displacer are located, and this solid volume displacer provides enhanced mixing by displacing the liquid upward and causing swirling eddy current for sufficient immersion and mixing of the liquid 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, Harris et al teach to add a reduced volume of liquid to the liquid container 3 equal to or greater than the volume of the liquid container 3 below the top of the dried reagent compositions on the solid support surface of the displacer 2 that the displacer 2 is not occupying. See Figure 2 and lines 18-24 in column 6 of Harris et al where it teaches to add only a small volume of liquid to the container 3 since the displacer 2 serves to displace the liquid upwards towards the dried reagent ligands on the solid support 10 of the displacer 2.
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 Harris et al teach that the liquid container is a tube or vial. See Figure 1 in Sharkey et al and Figure 2 in Harris et al.
With regards to claim 21, Harris et al teach that the solid volume displacer 2 is configured as a pestle since the fluid displacing member 18 at the end of the second end portion 8 of the solid volume displacer 2 has the configuration of a common pestle.
With regards to claims 24-25, Harris et al teach that the solid volume displacer 2 has a first or proximal end portion 6, a second or distal end portion 8, and an intermediate body 10 therebetween, wherein the second end 8 and the body 10 are configured to be positioned inside of the liquid container 3, and wherein the body 10 is configured as a solid cylinder. See Figures 1-2 in Harris et al which depict the body 10 of the displacer 2 as having a cylindrical shape with solid, dried ligand reagents adhered thereto.
With regards to claim 26, Harris et al teach that the body 10 of the solid volume displacer 2 comprises an outside surface that is concentric to the inner surface of the wall of the liquid container 3. See Figures 1-2 in Harris et al which depict the body 10 of the displacer 2 as having a cylindrical shape that is concentric to the inner surface of the wall of the liquid container 3.
With regards to claim 30, the combination of Sharkey et al and Harris et al 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 Harris et al 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 31, Harris et al teach that the first end portion 6 of the solid volume displacer 2 is configured to be positioned outside of the liquid container 3 when the body 10 and the second end portion 8 of the displacer are positioned inside of the liquid container 3. See Figure 2 in Harris et al.
With regards to claim 35, the combination of Sharkey et al and Harris et al fails to teach that the solid volume displacer in the system further comprises a ring of filer media positioned around the outside of the body near the first end 6. 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 6 of the solid volume displacer 2 taught by Harris et al and included in the reconstitution system taught by Sharkey et al with a ring of filter media positioned around the outside of the body 10 near the first end portion 6 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 10 of the displacer.
With regards to claim 38, the combination of Sharkey et al and Harris et al fails to teach that the solid volume displacer is hollow. 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 solid volume displacer 2 taught by Harris et al and included in the system taught by Sharkey et al as a hollow displacer because doing so would minimize manufacturing costs of the displacer.
With regards to claim 40, Harris et al teach that the second end portion 8 of the solid volume displacer 2 is rounded and concentric to the bottom of the liquid container 3. See Figure 2 and lines 23-27 in column 5 of Harris et al where it states “the configuration of the outer surface of the lower portion of member 18 substantially conforms with the configuration of the inside side wall 26 and the inner bottom wall 27 at the bottom region” of the container 3.
With regards to claim 51, Sharkey et al teach that the liquid container 12 can comprise a seal. See paragraph 0070 in Sharkey et al.
Claim(s) 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sharkey et al in view of Harris et al as applied to claims 1, 6-7, 9-10, 14-16, 20-21, 24-26, 30-31, 35, 38, 40 and 51 above, and further in view of Kilthau (US 3,464,798). For a teaching of Sharkey et al and Harris et al, see previous paragraphs in this Office action.
With regards to claim 32, the combination of Sharkey et al and Harris et al fails to teach that the first end 6 of the solid volume displacer 2 comprises a flange.
Kilthau teaches of a solid volume displacer for displacing a small amount of a liquid in a container or tube 30. The solid volume displacer comprises a first end 26, a second end 22 and a body 10 located between the first and second ends. A flange 24 is located near the first end 26 of the displacer for placing the displacer 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 10 and the inner sides of the tube 30. See Figures 1-3, lines 42-72 in column 2 and lines 1-9 in column 3 of Kilthau.
Based upon a combination of Sharkey et al, Harris 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 provide the first end 6 of the solid volume displacer 2 taught by Harris et al and included in the reconstitution system taught by Sharkey et al with a flange because Kilthau teaches that such a flange at the top end of a solid volume displacer provides a means for positioning the solid volume displacer at a desired height inside of the liquid container and a means for grasping the solid volume displacer.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Please make note of: Goos et al (US 2017/0165107) who teach of a device comprising a container and a solid volume displacer positioned inside of the container; Emerson et al (US 2022/0401959) who teach of dried dye reagent devices and methods for using; Carroll et al (US 2022/0241789) who teach of a container with a dried reagent composition and a method for using; Korpimaki et al (US 7,972,838) who teach of a reagent container having an inner surface upon which at least two reagents are dried in separate areas of the inner surface; and Knight (US 2017/0341073) who teach of a reagent well having a retention feature for retaining a lyophilized reagent.
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 February 25, 2026