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 .
DETAILED ACTION
Status of Claims
1. Claims 1-7 are pending. Claims 1-7 are under examination.
Priority
2. Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. This application is a continuation of United States Application Serial Number 17/407,154 filed 08/19/2021 which claims the benefit of Provisional Application Number 63/068,725 filed 08/21/2020. Based on the Filing Receipt, the effective filing date of this application is August 21, 2020 which is the filing date of Provisional Application Number 63/068,725 from which the benefit of domestic priority is claimed.
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.
3. Claims 1-7 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 is vague and indefinite in reciting “A method for delaying application of a chemical reagent to a lateral flow immunoassay” in the preamble which is directed to a method and then reciting in the first step “providing a lateral flow immunoassay comprising a membrane, an absorbent material …, and an adhesive coating” and in the second step “applying liquid to the lateral flow immunoassay” because
“lateral flow immunoassay (LFIA)” appears to properly define a process whereas “a membrane, an absorbent material containing a chemical reagent, and an adhesive covering” encompass structural components which are limitations drawn to a device such as a test strip. Applicant’s disclosure shows teachings of LFIA construct [0024, 0040], LFIA test strip [0005, 0007-0009, 0037-0039], LFIA device [0006, 0040, 0025], and LFIA system [0008]. Perhaps, Applicant intends “providing a lateral flow immunoassay test strip comprising a membrane, an absorbent material …, and an adhesive coating” and “applying liquid to the lateral flow immunoassay test strip….”
Claim 1 is further ambiguous in reciting “A method for delaying application of a chemical reagent to a lateral flow immunoassay” in the preamble and then reciting in the second step “applying liquid to the lateral flow immunoassay, wherein the membrane controls diffusion of the liquid into the absorbent material” because it fails to clearly define how the claimed membrane is configured to control the diffusion of the liquid into the absorbent material in a manner that delays application of the chemical reagent to the LFIA or what mechanism is involved to perform the functionality. In particular, the second step simply recites “applying a liquid” whereas it is unclear what is encompassed in the “liquid” and what properties the claimed liquid and/or the claimed membrane should have so as to enable control of diffusion of the liquid in manner that delays application of chemical reagent to the LFIA, with the chemical reagent being contained in the absorbent material.
Claim 1 is vague and indefinite as being incomplete for omitting essential structural and functional cooperative relationships of elements, such omission amounting to a gap between the necessary structural connections. See MPEP § 2172.01. In this case, it is unclear what is encompassed in the generic recitations of liquid, membrane, absorbent material, and chemical reagent in the LFIA test strip; what properties each of the recited components should have; and what essential structural and functional cooperative relationships exist between 1) the liquid and the membrane and 2) the liquid and the chemical reagent in the absorbent material; and what mechanisms of action are taking place between all these components in a manner that delays application of the chemical reagent, in question, so as to achieve its function in the claimed lateral flow immunoassay.
Claim 7 is ambiguous in relation to claim 1 from which it depends in reciting “wherein the absorbent material comprises absorbed color forming reagents” because it is unclear as to whether the instant recitation of “absorbed color forming reagents” is a further limitation of, and therefore encompasses, the “chemical reagent” recited in claim 1. Alternatively, it is unclear what essential structural and/or functional cooperative relationship exists between the instant “absorbed color forming reagents” and the “chemical reagent” recited in claim 1, both of which are contained in and comprises the absorbent material.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
4. Claims 1-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 11/885,801. Although the claims at issue are not identical, they are not patentably distinct from each other because both inventions recite a process that delays application of a chemical reagent to a lateral-flow immunoassay using a lateral flow immunoassay construct (release system) comprising a membrane, an absorbent material containing a chemical reagent, and an adhesive covering; wherein the membrane controls diffusion of a liquid into the absorbent material upon application into the lateral flow immunoassay construct. The membrane comprises a porous polymer and/or a fibrous material that is cellulose. The absorbent material comprises absorbent pad or absorbent string or further comprises a plurality of absorbent strings, absorbent pads, or any combination thereof; and the absorbent material comprises absorbed color forming reagents which comprise a phenylenediamine salt with a napthol or a phenol.
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.
5. Claims 1-6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Borse et al. (Process parameter optimization of lateral flow immunosensing. Materials Science for Energy Technologies 2: 434-441 (April 11, 2019)).
Borse et al. teach a method for delaying application of a chemical reagent to a lateral-flow immunoassay (LFIA). Delayed application of the chemical reagent to the LFIA is effected by strip component assembly and nitrocellulose membrane (NCM) morphology (Abstract; p. 435, left col. 1st 2nd full ¶; Figure 1). The method comprises providing a LFIA strip developed using optimized strip assembly comprising a membrane, an absorbent material containing a chemical reagent (IgG immobilized on the control line- used as a substrate for control line formation, capture antibodies immobilized on the test line), and an adhesive covering (plastic cover film; adhesive tape) (Abstract; p. 434, left col.; p. 435, left col. 3rd full ¶; 435, right col. 2nd full ¶; p. 436, left col. 2nd full ¶; Figure 1). The membrane comprises nitrocellulose membrane (NCM) which is a porous polymer comprising a fibrous material such as glass fiber or cellulose having varying pore sizes i.e. 5 µm, 8 µm, 10 µm, 15 µm. (Abstract; p. 435, left col. 1st 3rd full ¶, p. 436, left col. 2nd full ¶; Figure 1). The absorbent material comprises an absorbent pad or an absorbent string. The absorbent material comprises a plurality of absorbent pads or strings having high fluid capacity (Abstract; p. 435, right col. 1st full ¶; p. 436, left col. 2nd full ¶; Figure 1). Borse et al. teach applying liquid (sample solution, buffer solution) to the LFIA strip, and show that the NCM membrane controls diffusion of the liquid into the absorbent material with its excellent capillary flow (Abstract; p. 435, left col. 1st full ¶; p. 436, left col. 2nd full ¶ to right col. 1st full ¶; p. 437-438; Figure 5).
Accordingly, Borse et al. appears to read on Applicant’s 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.
6. Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Borse et al. (Materials Science for Energy Technologies 2: 434-441 (April 11, 2019)) in view of Kidwell et al. (Catalytics Nanoparticles to Enhance the Sensitivity of Lateral Flow Immunoassays. TeleConnect Briefs (June 17, 2019)).
Borse et al. is discussed supra. Borse et al. differ from the instant invention in failing to teach that the absorbent material comprises absorbed color forming reagents.
Kidwell et al. teach providing a test system which is a catalytic lateral flow immunoassay (cLFIA) test strip which comprises a membrane and an absorbent material in the form of an absorbent pad containing a chemical reagent (Figure 1: Enhanced LFIA). Kidwell et al. specifically designed the cLFIA test strip to incorporate three color forming chemical reagents (elements) into the cLFIA test strip; thereby, requiring no additional steps in performing the LFIA (p. 427, right col. 2nd full ¶; Figure 1: Enhanced LFIA). The three chemical elements react with palladium nanoparticle (quantum dots: QD) labels to produce a measurement signal. The chemical elements are absorbed color forming reagents which comprise a phenylenediamine salt with a napthol or a phenol (Figure 1: Enhanced LFIA; Figure 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to incorporate the chemical reagents for cLFIA of Kidwell into the LFIA test strip method of Borse because Kidwell taught that substitution of cLFIA chemical reagents have demonstrated an increase in sensitivity without placing undue burden to the user. One of ordinary skill would have had reasonable expectation of success in incorporating the teaching of Kidwell into the LFIA test strip method as taught by Borse because Kidwell taught a design that incorporates absorbed color forming chemical reagents into absorption pad components of cLFIA test strip and both of Borse and Kidwell teach analogous art in improving LFIA test strips and techniques.
7. No claims are allowed.
Remarks
8. Prior art made of record are not relied upon but considered pertinent to the applicants' disclosure:
Kouvonen et al. (U.S. Patent 5,712,170) disclose a test strip for rapid immunoassay containing immunological reagents (Abstract).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GAILENE R. GABEL whose telephone number is (571)272-0820. The examiner can normally be reached Monday, Tuesday, and Thursday 5:30 AM to 4:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Gregory S. Emch can be reached at (571) 272-8149. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/GAILENE GABEL/Primary Examiner, Art Unit 1678
June 26, 2026
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