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 .
Status of Claims
The claim set submitted on 13 FEBRUARY 2023 is considered. In the claim set, Claims 1-20 are presented and acknowledged.
Claims 1-20 are pending and are considered on the merits below.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 17 AUGUST 2023 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
Claim 20 is 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.
The instant claim is directed towards a method of using, however, there are no positively claimed method steps recited. It is unclear to the Examiner what is being claimed.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1 and 3-20 are rejected under 35 U.S.C. 102(a)(1) and 102 (a)(2) as being anticipated by GLEZER, US Publication No. 2007/0202538 A1, submitted on the Information Disclosure Statement on 17 AUGUST 2023, US Patent Application Publications Cite. No. 1.
Applicant’s invention is directed towards a device, a reagent container device.
Regarding Claim 1, the reference GLEZER discloses a reagent container device , Figure 5a-d, [0090-0093], comprises:
a) a container that can be sealed, Figure 5a-d, in particular 5b, 5d, container is considered combination of 501/502 or 521/522 sealed by seal 515 or 527, [0090-0093], and
b) a support system that forms a grid for sealing the top of the container, Figure 5a-d, [0090-0093], wherein the support system does not restrict liquid flow in the container, Figure 5a-d, flow is in 508/524, [0090-0093].
Additional Disclosures Included are: Claim 3: wherein the reagent container device of claim 1, wherein the container device is constructed of a plastic material, Figure 6, [0074, 0096].; Claim 4: wherein the reagent container device of claim 3, wherein the plastic material is high density polyethylene (HDPE) or low density polyethylene (LDPE), [0074, 0096].; Claim 5: wherein the reagent container device of claim 1, wherein the container device is capable of storing reagents, [0013, 0068]. It should be noted that the instant claim language does not structurally limit the device itself but is directed to language of its intended use and how it is to be used. ; Claim 6: wherein the reagent container device of claim 1, wherein the container device is filled with reagents prior to sealing, [0013, 0064, 0091].; Claim 7: wherein the reagent container device of claim 1, wherein the container device is accessed by 96- pipet tips in the Society for Biomolecular Screening (SBS) format simultaneously, [0013, 0018, 0021, 0023, 0064, 0091], Claim 16, 26, 27. It should be noted that the instant claim language does not structurally limit the device itself but is directed to language of its intended use and how it is to be filled. This instant claim language is given a relative amount of patentable weight. Since the prior art modules can be pre-loaded in the wells, chambers, or assay regions and they are sufficiently small, to fill small spaces, it is known in the art to uses pipette (pipet) tip or syringes to accurately fill small spaces. ; Claim 8: wherein the reagent container device of claim 1, wherein the container device is dimensions compatible with society of biomolecular screening, [0010, 0051, 0089]. ; Claim 9: wherein the reagent container device of claim 1, wherein the container device is composed of a single section or compartment, Figure 5a-d, one of 501/502 or 521/522 can be considered to be a single section or compartment, [0090-0093].; Claim 10: wherein the reagent container device of claim 1, wherein the container device is composed of multiple sections or compartments, Figure 5a-d, see multiple of 501/502 or 521/522 which are multiple sections are compartments.; Claim 11: wherein the reagent container device of claim 1, wherein the support system grid is sealed with adhesive tape and/or film, [0095].; Claim 12: wherein the reagent container device of claim 1, wherein the support system grid is sealed with heating-sealing tape and/or film, [0095].; Claim 13: wherein the reagent container device of claim 1, wherein seal can withstand chemical solvents, [0074, 0096]. The prior art discloses sealing may be accomplished through traditional sealing techniques such as adhesives, solvent welding, heat sealing, sonic welding and the like and may be protected from the outside environment by sealing (e.g., via traditional sealing techniques), [0095]. Since GLEZER teaches the seal used in the prior art is accomplished through traditional sealing techniques, the seal would be expected to ‘withstand’ chemical solvents as required by the instant claim. In re Best, 562 F.2d 1252, 1255 n.4, 195 USPQ 430, 433 n.4 (CCPA 1977), Ex parte Levy, 17 USPQ2d 1461, 1464 (Bd. Pat. App. & Inter. 1990).; Claim 14: wherein the reagent container device of claim 13, wherein the chemical solvent is ethanol or isopropanol, [0074]. It should be noted that the instant claim language is directed towards material to be worked upon by the device and does not limit the device structurally. Thus, “[i]nclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims.” In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963); see also In re Young, 75 F.2d 996, 25 USPQ 69 (CCPA 1935).; Claim 15: wherein the reagent container device of claim 1, wherein seal can withstand stand transport from conventional shipping conditions, [0095]. The instant claim language does not further define the device itself, but rather it directed to how the overall device to be used, to “withstand transport from conventional shipping conditions”. The prior art discloses sealing may be accomplished through traditional sealing techniques such as adhesives, solvent welding, heat sealing, sonic welding and the like and may be protected from the outside environment by sealing (e.g., via traditional sealing techniques), [0095]. Since GLEZER teaches the seal used in the prior art is accomplished through traditional sealing techniques, the seal would be expected to “withstand transport from conventional shipping conditions”. Furthermore, an “[A]pparatus claims cover what a device is, not what a device does.” Hewlett-Packard Co.v.Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990). A claim containing a “recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).; Claim 16: wherein the reagent container device of claim 1, wherein seal is removable, Figure 5a, [0091], one or more sets of wells may be unsealed and used.; Claim 17: wherein the reagent container device of claim 1, wherein the grid does not create additional section or well within the container device, Figure 2a – j (shows several embodiments of well that may be used), Figure 5a-d.; Claim 18: wherein the reagent container device of claim 1, wherein greater than 200 mL liquid can be placed in the container without restricting flow of liquid, [0084].; Claim 19: wherein the reagent container device of claim 1, wherein a maximum 18 mm is allowed from a seal contact point, [0084], Figure 5b, 5d, 5f.; and Claim 20: wherein discloses is a method of using the reagent container device of claim 1, see Rejection of Claim 1 above, for storing and transporting one or more reagents with or without a biological sample, Claim 19, [0064, 0074].
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim Rejections - 35 USC § 103
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 2 is rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over GLEZER, US Publication No. 2007/0202538 A1, submitted on the Information Disclosure Statement on 17 AUGUST 2023, US Patent Application Publications Cite. No. 1.
Regarding Claim 2, the GLEZER reference discloses the reagent container device of claim 1, see Rejection of Claim 1 above, Figure 5a-d, but does not specifically teach wherein the container device is disposable.
However, the instant claim language does not further define the reagent container device structurally, but recites what is to be done with the device after use. While GLEZER teaches the device structurally it does not specifically state that the container is disposable, but it would be obvious to one having ordinary skill in the art before the effective filing date to dispose the container after use of conducting assays to prevent any cross contamination between uses or tests and to maximize convenience, ensure hygiene and safety and reduce labor costs. Furthermore, any item is well known in the art to be disposable.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINE T MUI whose telephone number is (571)270-3243. The examiner can normally be reached M-Th 5:30 -15:30 EST.
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CTM
/CHRISTINE T MUI/Primary Examiner, Art Unit 1797