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 .
Claim Status
The amendment of 10/22/2025 has been entered. Claims 1-18 are pending in this US patent application. Claims 17-18 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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.
Withdrawn Rejections
The rejections of the claims under 35 U.S.C. 112(b) for being indefinite as set forth in the previous Office action are withdrawn in light of the amendment of 10/22/2025, which amended claims 1-2, 10, and 13 to be definite.
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 remain 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 remain 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.
Response to Arguments
Applicant has traversed the above rejection of the claims under 35 U.S.C. 103 as being unpatentable over Loke in view of Wang. Applicant states that the cited references do not teach the caps of the reagent tubes serving as reservoirs for the active components or the screw-on process of the caps (remarks, page 7). This argument has been fully considered but has not been found persuasive.
The Examiner notes that any cap on a tube that has been extensively rotated with liquid inside as taught by the combination of Loke and Wang would contain at least some amount of the reagents contained within the tube at at least some point during the period when the tube contains the reagents. The instant claims are drawn to an apparatus, not to a method of containing reagents in a cap, and do not structurally limit the shapes of the caps or the amounts of the various reagents that are contained therein.
Applicant states that Loke and Wang do not teach a support apparatus in which the sample tubes are positioned parallel to each other and horizontally to the top (remarks, page 7-8). This argument has been fully considered but has not been found persuasive.
The Examiner notes that the instant claims do not recite a support apparatus in which the sample tubes are positioned horizontally to “the top.” The Examiner further notes that any surface of an apparatus may be considered the “top” because an apparatus is limited only by its structure, not by the orientation in which it is positioned. The cited references render obvious the structure that is recited in the instant claims, which is all that is required for a rejection under 35 U.S.C. 103. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Applicant states that Loke and Wang teach devices that are used in a different manner than the instantly recited apparatus, and so one of ordinary skill in the art would have no reason and/or motivation to refer to Loke and Wang for a holder that “saves as much space as possible.” Applicant states that Loke’s kit contains large components and is packed in protector transit cases, which Applicant states does not have dimensions that are comparable with a portable test kit as instantly recited (remarks, pages 8-9). This argument has been fully considered but has not been found persuasive.
The Examiner notes that the instant claims do not recite any particular size or dimensions for the apparatus, nor do they preclude the inclusion of “relatively large electrical components” or any other components that are not recited. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Additionally, an apparatus is not limited by its intended use but, rather, by its structure. The combination of Loke and Wang renders obvious every structural element that is recited in the instant claims. As such, the teachings of Loke and Wang are sufficient for a rejection under 35 U.S.C. 103, regardless of whether or not Loke and Wang teach the same use for the apparatus as Applicant intends.
Therefore, the Examiner has maintained the rejections presented above.
Conclusion
No claims are allowed.
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 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 12/20/2025
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