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 .
Election/Restrictions
Applicant’s election without traverse of the invention of Group I, claims 1-16, in the reply filed on 05/07/2025 is acknowledged.
Claim Status
The amendment of 05/07/2025 has been entered. Claims 1-18 are pending in this US patent application. Claims 17-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/07/2025.
Claims 1-16 are currently under examination and were examined on their merits.
Information Disclosure Statement
The information disclosure statements filed in this application on 08/23/2022, 03/16/2023, and 01/14/2025 have been received and considered.
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 1-16 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 1 recites “the second active component” in line 7. However, claim 1 does not recite a second active component prior to this recitation. Accordingly, “the second active component” in claim 1 lacks clear antecedent basis, which causes confusion because it is unclear which of the reagents listed in claim 1 is intended to be “the second active component.” Similarly, claims 10 and 13 depend from claim 1 and recite “the test tube” and “the packaged test kit,” respectively, but claim 1 does not recite a test tube or a packaged test kit. Accordingly, claims 10 and 13 lack clear antecedent basis to claim 1, which causes confusion because it is unclear which of the tubes in claim 1 is to be the “test tube” of claim 10 or whether the test kit of claim 1 is intended to be the same as the “packaged test kit” of claim 13. As such, one of ordinary skill in the art would be unable to determine the metes and bounds of claims 1, 10, and 13, rendering them indefinite.
Regarding claim 2, the phrases "preferably" and “such as” render the claim indefinite because it is unclear whether the limitations following the phrases are part of the claimed invention. See MPEP § 2173.05(d). As such, claim 2 is rejected under 35 U.S.C. 112(b).
Because claims 2-16 depend from claim 1 and do not provide any clarification of the indefinite language therein, these claims are also indefinite. Therefore, claims 1-16 are rejected under 35 U.S.C. 112(b).
In the interest of compact prosecution, the Examiner has interpreted “the second active component” to be any of the reagents in claim 1 other than the acetylcholinesterase, which is designated as the “first active component.” The Examiner has interpreted claim 2 without the limitation following the word “preferably”. The Examiner has interpreted “the test tube” of claim 10 as the sample tubes of claim 1. The Examiner has interpreted “the packaged test kit” of claim 13 as the test kit of claim 1.
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.
Claims 1-12 and 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over US patent application publication 2010/0062455 filed by Loke et al., published 03/11/2010, in view of Chinese patent application CN 211562730 filed by Wang, published 09/25/2020 (cited on the IDS filed 01/14/2025).
Please note that the page/paragraph numbers cited in this Office action for the Wang reference correspond to the English translation of Wang attached to this action.
Loke teaches methods and kits for the rapid detection of cholinesterase inhibitors (see entire document, including page 1, paragraph 0001; cf. claims 1 and 14). The cholinesterase inhibitors may be detected by a cholinesterase enzyme in a chromogenic assay including a substrate, such as acetylthiocholine, and a chromogen, such as DTNB (page 4, paragraph 0064; cf. claim 1). The cholinesterase inhibitors may include sarin, soman, pesticides, tabun, VR, and VX (page 5, paragraph 0066; cf. claims 15-16). The cholinesterase may be acetylcholinesterase and may come from a human source (page 5, paragraph 0074; cf. claims 1 and 11). The kit may further comprise a buffered solution (page 6, paragraph 0078; cf. claim 1). The kit may include two or more walled columns or tubes (page 6, paragraph 0084; cf. claim 1). The sample tested may be blood (page 4, paragraph 0057). The kit may comprise pipette tips and safety lancets, and the tubes may be heparinized (page 6, paragraph 0080; cf. claim 1 [“…a sampling device”]). The components of the kit may be packaged into a transit case (page 6, paragraph 0091; cf. claim 12; the Examiner notes that labeling the outside of a transit case would be obvious to one of ordinary skill in the art so that the contents of the case would be discernible). Constructing elements of the kit from plastic makes the kit more rugged and less fragile (page 17, paragraph 0193; cf. claim 2).
However, Loke does not teach that the kit also includes a support apparatus as recited in instant claim 1.
Wang teaches a self-spinning negative pressure blood collection tube (see entire document, including paragraph 0002). After the sample is collected into the anticoagulant-containing tube, the blood collection tube is placed within the clamping device and rotated to fully incorporate the anticoagulant into the blood, thereby enhancing the anticoagulant effect (paragraphs 0014-0015; cf. claims 5-6). Following the mixing, the tube is moved to the placement rack for detection (paragraph 0026). Figure 1 shows that the tubes are capped, that the recess in which the tube is clamped for mixing is circular, and that the placement rack has an upper side and an underside, more than four fixing devices arranged in rows that are circular recesses in the support apparatus for receiving the sample tubes, the sample tubes are fixed parallel to the upper side of the support apparatus, and wherein the support apparatus has at least two receiving devices for receiving the first and the second reagent caps and a receiving device for vertically receiving a sample tube (Figure 1, 3-4, and 7-10; cf. claims 1; the Examiner notes that, as an apparatus can be oriented in any direction, the “upper side” and “underside” of the apparatus can be any surface of the apparatus, and any direction can be interpreted as “vertically receiving” a sample tube; the recesses that receive the capped tubes can also be interpreted as “receiving” the caps of the tubes).
While Loke does not teach that the heparinized blood sample tubes in which the samples for testing for acetylcholinesterase inhibitors using a kit containing human acetylcholinesterase, acetylthiocholine, and DTNB in the method rendered obvious by their teachings are placed in a mixing device and storage rack such as that taught by Wang, it would have been obvious to one of ordinary skill in the art to do so because Wang teaches that mixing anticoagulant-containing blood sample tubes in their device and then placing them in the placement rack for further analysis results in the more complete mixing of the anticoagulant with the blood and the improvement of the anticoagulant effect (the Examiner notes that heparin, as taught by Loke, is an anticoagulant). While Loke does not teach that the sample containers that hold the buffer, the acetylcholinesterase, and the assay reagents have caps, it would have been obvious to one of ordinary skill in the art to cap the containers to prevent loss of the material. While Wang does not teach that the placement rack comprises plastic as recited in instant claim 2, it would have been obvious to one of ordinary skill in the art to construct at least part of the rack from plastic because Loke teaches that having contents of the kit made from plastic makes the kit less fragile. One of ordinary skill in the art would have a reasonable expectation that processing the sample tubes of Loke in the device of Wang containing the plastic of Loke and then performing the assay of Loke on the processed samples with the reagents stored in sealed containers in the kit would successfully result in the improved anticoagulation of the blood in the sample tubes, thereby simplifying the subsequent assay and analysis steps, as well as the detection of organophosphate compounds in the samples.
Loke and Wang do not explicitly teach the reagent container shapes, the arc lengths/diameters/depths of the holes in the tube racks, the arrangement of recesses between the mixing devices, and the presence of multiple mixing/clamping devices as recited in instant claims 1 and 6-10. However, the Examiner notes that MPEP § 2144.04 states that changes in size/shape, duplication of parts, and rearrangement of parts are routine expedients that require only ordinary skill in the art in the absence of a demonstration of the criticality of the design changes.
Therefore, claims 1-12 and 14-16 are rendered obvious by Loke in view of Wang and are rejected under 35 U.S.C. 103.
Claims 1-16 are rejected under 35 U.S.C. 103 as being unpatentable over US patent application publication 2010/0026455 filed by Loke et al., published 03/11/2010, in view of Chinese patent application CN 211562730 filed by Wang, published 09/25/2020 (cited on the IDS filed 01/14/2025), and US patent application publication 2014/0073990 filed by Holmes et al., published 03/13/2014.
As discussed above, claims 1-12 and 14-16 are rendered obvious by Loke in view of Wang. However, these references do not teach that the heparinized tubes for collecting blood have screw caps as recited in instant claim 13.
Holmes teaches that containers and caps for collecting blood may be threaded to permit a screw-type engagement between container and cap (see entire document, including page 27, paragraphs 0248-0249; cf. claim 13).
While Loke and Wang do not teach that the heparinized tubes for collecting blood have screw caps as recited in instant claim 13, it would have been obvious to one of ordinary skill in the art to use any known manner of connecting the caps of the blood collection tubes to the container bodies, including the screw mechanism taught by Holmes for use in blood collection containers. One of ordinary skill in the art would have a reasonable expectation that using heparinized blood collection tubes with the screw caps taught by Holmes in the method rendered obvious by Loke and Wang would successfully result in the ability to determine whether organophosphates are present in the blood collected in the tubes.
Therefore, claims 1-16 are rendered obvious by Loke in view of Wang and Holmes and are rejected under 35 U.S.C. 103.
The Supreme Court has acknowledged:
When a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one. If a person of ordinary skill can implement a predictable variation…103 likely bars its patentability…if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond that person’s skill. A court must ask whether the improvement is more than the predictable use of prior-art elements according to their established functions……the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results (see KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 U.S. 2007) (emphasis added).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Erin M. Bowers, whose telephone number is (571)272-2897. The examiner can normally be reached Monday-Friday, 7:30-5:00.
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/Erin M. Bowers/Primary Examiner, Art Unit 1653 07/23/2025