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
Claims 1-20 are pending and examined.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
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 5 and 14 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.
Regarding claim 5, the terms “a stable property”, “a large water absorption capacity”, and “a desirable water absorption performance” are relative terms which render the claim indefinite. The terms “a stable property”, “a large water absorption capacity”, and “a desirable water absorption performance” are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. In this case, it is unclear what property would be considered stable or unstable, or how long a property must endure in order to be considered stable, what level of water absorption capacity must be present to be considered large, and what level of water absorption performance must be present to be considered desirable. Further clarification is needed.
Claim 14 contains similar issues regarding the recitation of the terms “a stable property”, “a large water absorption capacity”, and “a desirable water absorption performance”, and is similarly rejected.
Allowable Subject Matter
Claims 1-4, 6-13, and 15-20 are allowed.
Claims 5 and 14 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is an examiner’s statement of reasons for allowance:
Sabir et al. (US Pub. No. 2024/0418719; hereinafter Sabir), Rurack et al. (US Pub. No. 2020/0340989; hereinafter Rurack), Qasaimeh et al. (US Pub. No. 2023/0114400; hereinafter Qasaimeh), Ceballos et al. (US Pub. No. 2025/0362294; hereinafter Ceballos), Araoz et al. (US Pub. No. 2019/0004043; hereinafter Araoz), Reinhartz et al. (US Pub. No. 2011/0189792; hereinafter Reinhartz), Zhang (US Pub. No. 2024/0085409), Donnelly (US Pub. No. 2021/0278423), and Adornetto et al. (US Pub. No. 2021/0129138; hereinafter Adornetto) teach a device similar to that claimed. However, Sabir, Rurack, Qasaimeh, Ceballos, Araoz, Reinhartz, Zhang, Donnelly, and Adornetto do not teach, either alone or in combination with the prior art, a backing card for supporting a sample pad, conjugate pad, test region, and absorbent pad, where the backing card is a transparent glass, an upper surface of the transparent glass is provided with the test region, and a nitrocellulose membrane is arranged above the test region, where the transparent glass is pretreated by silanization. Specifically, although Adornetto, which is considered to be the closest art, teaches a backing card for supporting a sample pad, conjugate pad, test region, absorbent pad, and nitrocellulose membrane, where the backing card comprises glass (Adornetto; [0004]-[0009], [0044]-[0054], [0072], see Fig. 1 at lateral flow test arrangement 1 comprising carrier 70, which may be glass, the carrier 70 supporting sample pad 10, conjugate pad 20, test line 40, wicking pad 60, which is absorbent, and membrane pad 30, which is preferably made of nitrocellulose), both Adornetto and the prior art as a whole is silent on the backing card being a glass that is pretreated by silanization. Further, in Adornetto, the test region is part of the nitrocellulose membrane (Adornetto [0044]), rather than part of the backing card. Modifying Adornetto so that the glass is pretreated by silanization, and the test region is part of the backing card, would have impermissibly modified the principle of operation of Adornetto. See MPEP 2143.01(VI). Further, although Reinhartz teaches utilizing silanized glass in an assay device (Reinhartz; [0083], [0205], see Fig. 2 at capturing matrix 26, which may be a silanized glass), the silanized glass in Reinhartz is used as a capturing matrix separate from the backing card, and therefore modifying Adornetto with the teachings of Reinhartz would not have resulted in a lateral flow immunoassay device having a backing card that is a transparent glass pretreated by silanization.
Claims 2-4, 6-13, and 15-20 are allowable for depending from an allowed claim. Claims 5 and 14 would be allowable for depending from an allowed claim.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to John McGuirk whose telephone number is (571)272-1949. The examiner can normally be reached M-F 8am-530pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Capozzi can be reached at (571) 270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOHN MCGUIRK/Examiner, Art Unit 1798
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