. Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 29-34 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Specifically, in In re Wands the Court set forth a non-exhaustive list of factors to
be considered in determining whether undue experimentation would be involved in making and/or using the claimed invention. These factors include, but are not limited to:
(a) the breadth of the claims; (b) the nature of the invention; (c) the state of the prior art;(d) the level of one of ordinary skill; (e) the level of predictability in the art; (f) the amount of direction provided by the inventor; (g) the existence of working examples; and (h) the quantity of experimentation needed to make or use the invention based on the content of the disclosure.
1) Breadth of the claims - Claim 29 is directed to a competitive lateral flow assay device for detecting an antineoplastic drug comprising a conjugate pad, a solid or semi-solid porous support adjacent the conjugate pad, a test zone present on the support and a control zone present on the support, wherein the conjugate pad comprises a diffusibly bound detectably labelled antineoplastic drug antibody to which the antineoplastic drug binds, wherein the test zone comprises a non- diffusibly bound antineoplastic drug which binds to the anti-neoplastic drug antibody, and the control zone comprise a non-diffusibly bound control reagent that binds specifically to the anti-neoplastic drug antibody, wherein the solid or semi-solid porous support is adjacent a wicking pad that promotes capillary flow of a fluid test sample along a flow path including the conjugate pad and the solid or semi-solid porous support. And a fluid test sample is disposed in the competitive lateral flow assay device.
2) The nature of the invention – A lateral flow assay device for performing a competitive immunoassay to detect an antineoplastic drug.
3) The state of the prior art – The prior art discloses lateral flow assay device comprising conjugate pads, solid or semi-solid porous supports with test and control zones, and wicking pads for performing competitive assays on samples that are applied to the disclosed lateral flow assay devices, see U.S. Patents 5,384,264, 5,602,040, and 6,492,127. U.S. 2008/0138842 discloses a lateral flow assay device for the detection of antineoplastic drugs in samples that are applied to the lateral flow assay device. But the prior art does not disclose lateral flow assay devices where a sample is already on the device prior to its use to perform an assay as if the sample were a component of the device.
4) The level of one of ordinary skill - A person who is able to use a competitive lateral flow assay device to assay a sample.
5) The level of predictability in the art – Low because using a lateral flow assay device that already has a sample on the device will not yield accurate or usable results on the sample that is to be assayed.
6) Amount of direction provided by the inventor -The amount of direction
provided by the inventor does not make it clear how to make or use the invention
commensurate with the claims. The specification teaches that the function of the disclosed lateral flow assay device is to assay a sample for the presence of antineoplastic drugs. If there is already a sample on the device then it cannot perform its intended function – assaying a sample that is applied to the device. The specification does not provide any guidance on how the disclosed device can assay a sample when a sample is already disposed thereon, as reflected in the instant claims. With the sample already on the device, reagents on the device will have been reacted and there would be little or no reagents left to assay the sample is to be assayed.
7) The existence of working examples – There are no working example
provided in the specification where a sample can be assayed when the disclosed lateral flow assay device already has a sample disposed thereon.
8) Quantity of experimentation - Many experiments will be necessary to
determine how one could assay a sample with a lateral flow device that already has a sample disposed thereon.
In light of the above factors, it is concluded that the claimed competitive lateral assay device is not enabled.
4. Claims 29-34 are free of the prior art because the prior art does not disclose lateral flow assay devices where a sample is already on the device prior to its use to perform an assay as if the sample were a component of the device.
Response to Arguments
5. Applicant's arguments filed 3/11/26 have been fully considered but they are not persuasive.
In response to the 112(a) rejection for lack of enablement, Applicants argue that the amendment to the preamble of claim 29 defines the sample as the sample that is to be assayed. Thus, the Examiner's concerns about how the device can be used to analyze a sample when the reagents have already been used to analyze a previously applied sample are moot - the sample disposed in the sample pad of the device is the sample to be assayed.
Applicant’s arguments have been considered but are not convincing because lines 14-15 of claim 29 recite a fluid test sample as being in the sample pad of the claimed lateral flow assay device so the fluid test sample is a part of the claimed lateral flow assay device. A subsequently applied sample cannot be assays on the claimed lateral flow assay device.
Conclusion
6. THIS ACTION IS MADE FINAL. 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.
7. Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER L CHIN whose telephone number is (571)272-0815. The examiner can normally be reached Monday - Friday, 10:00am - 6:30pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bao-Thuy Nguyen can be reached at 571-272-0824. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHRISTOPHER L CHIN/Primary Examiner, Art Unit 1677
6/4/2026
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