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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 3/10/2023 is being considered by the examiner.
Claim Objections
Claim 18 is objected to because of the following informalities:
In claim 18, line 3, “the swab” should be –the swab, and --.
Appropriate correction is required.
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 1-20 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 pre-AIA the applicant regards as the invention.
Claim 1 recites the limitation "the analyte-specific labeled reagent" in line 16, “the assay” in line 23, and “the distal end” in line 24. There is insufficient antecedent basis for these limitations in the claim.
Claims 2-18 inherit the deficiencies of claim 1 and are likewise rejected.
Claim 6, line 3 recites “a sample receiving portion”. It is not clear if this is a new instance or the same instance mentioned in line 11 of claim 1.
Claim 10 recites the limitation "the solvent" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 15 recites the limitation "the application" in line 4 and “the subject” in line 5. There is insufficient antecedent basis for these limitations in the claim.
Claim 18, line 5 recites “a sample receiving portion”. It is not clear if this is a new instance or the same instance mentioned in line 11 of claim 1.
Claim 19 recites the limitation "the binding" in line 13 and “the labeled analyte-indicator complex” in lines 13-14. There is insufficient antecedent basis for these limitations in the claim.
Claim 20 recites the limitation "the reaction" in line 8, “the second non-volatile reagent” in line 9, and “the lateral flow immunochromatographic assay device” in line 17. There is insufficient antecedent basis for these limitations in the claim.
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.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 10,596,573. Although the claims at issue are not identical, they are not patentably distinct from each other because U.S. Patent No. 10,596,573 claims a species that anticipates the current genus claims.
The current claims are mapped to the following patent claims:
Claim 1 is disclosed by claim 1 of US 10,596,573.
Claim 2 is disclosed by claim 2 of US 10,596,573.
Claim 3 is disclosed by claim 1 of US 10,596,573.
Claim 4 is disclosed by claim 3 of US 10,596,573.
Claim 5 is disclosed by claim 1 of US 10,596,573.
Claim 6 is disclosed by claim 4 of US 10,596,573.
Claim 7 is disclosed by claim 5 of US 10,596,573.
Claim 8 is disclosed by claim 6 of US 10,596,573.
Claim 9 is disclosed by claim 7 of US 10,596,573.
Claim 10 is disclosed by claim 8 of US 10,596,573.
Claim 11 is disclosed by claim 9 of US 10,596,573.
Claim 12 is disclosed by claim 10 of US 10,596,573.
Claim 13 is disclosed by claim 11 of US 10,596,573.
Claim 14 is disclosed by claim 12 of US 10,596,573.
Claim 15 is disclosed by claim 13 of US 10,596,573.
Claim 16 is disclosed by claim 14 of US 10,596,573.
Claim 17 is disclosed by claim 15 of US 10,596,573.
Claim 18 is disclosed by claim 16 of US 10,596,573.
Claim 19 is disclosed by claim 17 of US 10,596,573.
Claim 20 is disclosed by claim 18 of US 10,596,573.
For each claim, U.S. Patent No. 10,596,573 discloses a more specific instance of the claim, thus anticipating the current genus claims.
Claims 19 and 20 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 16 and 17 of U.S. Patent No. 11,602,749. Although the claims at issue are not identical, they are not patentably distinct from each other because US 11,602,749 claims a species that anticipates the current genus claims.
The claims are mapped to the following patent claims:
Claim 19 is disclosed by claim 16 of US 11,602,749.
Claim 20 is disclosed by claim 17 of US 11,602,749.
For each claim, U.S. Patent No. 11,602,749 discloses a more specific instance of the claim, thus anticipating the current genus claims.
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.
Claims 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2008/0299648 (Tomer) and US 5,494,801 (Bogart et al., hereinafter Bogart).
Regarding Claim 1, Tomer discloses a device, comprising:
a swab comprising an absorptive component attached to a stem (Figs. 1A, 3A, 3B; para [0021], [0022], sampling unit, 11, with sampling element, 36... swab.), an extraction chamber configured to receive the swab and position the absorptive component of the swab configured to be in fluid communication with an extraction reagent (Figs. 1A, 3A, 3B, 5: para [0021], [0022], sampling element, 36... dipped in fluid solution, 52, that is a reagent for extraction.),
wherein the extraction chamber is filled with an extraction reagent, a test strip configured to be brought in fluid communication with the extraction reagent following extraction of an analyte from the biological sample (Figs. 1A, 3A, 4A, 4B, 5: para [0021], [0022], fluid solution, 52, that is a reagent for extraction... strip unit, 20, with sample wick, 28, for directing and aiding capillary action advancement of the analyzed liquid to the test strip.), comprising:
a sample receiving portion configured to accept a sample (Figs. 4B, 5; para [0021], [0022], sampling element, 36, such as swab... with sample, 60.),
wherein the sample is a liquid sample (para [0025], sample from a surface such as a vaginal surface.), and
wherein the sample receiving portion is configured to permit the movement of an analyte in the liquid sample through the test strip by capillary action (Figs. 3B, 4A; para [0021], lateral flow membrane, 22, provide chromatographic presentation of analytes due to the analysis of fluid advancing in capillary action within the membrane, 22.),
a site on the strip where the analyte-specific labeled reagent has been incorporated, wherein the analyte-specific labeled reagent is configured to bind the analyte from the biological sample (para [0006], [0034], signal reagent binds to the antigen or antibody in the sample and moves through the membrane by capillary action... for test positive a pink/purple/red line develops.), and
wherein the analyte-specific labeled regent is comprised of a molecule that binds the analyte specifically and with high affinity and is further labeled with a label that allows its detection (para [0005], [0031], test sensitivity using colloidal gold conjugated to polyclonal antibodies anti-Candida that are used for the capture line... wherein the colloidal gold generates the signal that indicates a positive result.),
a capture portion configured to receive the analyte from the biological sample and the analyte-specific labeled reagent so as to result in displaying a positive or negative result at the completion of the assay (Fig. 3B; para [0023], [0034], lateral flow membrane, 22, with analysis results at line, 46, and control, 44... positive result resulted in red line and a negative result did not result in any red line.), and
an adsorbent pad attached to the distal end of the test strip and configured to bind to an excess extraction reagent thereby allowing flow across the test strip (Fig. 4A; para [0021], lateral flow absorbent wick, 32, enables the advancement of the fluid flow from the sample wick, 28, through membrane, 22.).
Tomer does not specifically disclose that the absorptive component comprises a non-volatile reagent. However, Bogart discloses sampling of an analyte for extraction using a non-volatile reagent (col 2, ln 37-54; col 3, ln 57-65; col 6, ln 37-44; col 9, ln 17-26; extraction and detection of antigens using acid reagent and nitrite salt... with a coated binding surface.). To a person of ordinary skill in the art, before the filing date of the claimed invention, it would have been obvious to substitute a non-volatile reagent as taught by Bogart for use in the swab device as in Tomer in order to test for desired microorganisms such as Streptococci (col 2, ln 55-63; col 4, ln 33-40), because Tomer and Bogart are directed towards swab extraction devices for use with mucus and vaginal surfaces (col 2, ln 1-15; col 10, ln 33-49).
In regards to claim 2, Tomer and Bogart disclose the limitations of claim 1. In addition, Bogart further discloses, that the analyte is Streptococcus Group A Carbohydrate Antigen (col 3, ln 16-24; col 6, ln 10-18).
In regards to claim 3, Tomer and Bogart disclose the limitations of claim 1. In addition, Bogart further discloses that the extraction reagent is a nitrite salt (col 3, ln 60-65).
In regards to claim 4, Tomer and Bogart disclose the limitations of claim 1. In addition, Bogart further discloses that the extraction reagent is 0.2-5M nitrite salt solution (col 5, ln 51-56).
In regards to claim 5, Tomer and Bogart disclose the limitations of claim 1. In addition, Bogart further discloses that the non-volatile reagent is acidic (col 3, ln 50-56).
In regards to claim 6, Tomer and Bogart disclose the limitations of claim 1. Tomer further discloses wherein the swab and test strip are configured to be in fluid communication, so as to result in capillary flow from the absorptive component of the swab to a sample receiving portion of the test strip (Figs. 1A, 3A, 4A, 4B, 5: para [0021], [0022], fluid solution, 52, that is a reagent for extraction... strip unit, 20, with sample wick, 28, and conjugate pad, 30, for directing and aiding capillary action advancement of the analyzed liquid to the test strip.).
In regards to claim 7, Tomer and Bogart disclose the limitations of claim 1, Tomer further discloses wherein the stem may be solid, porous, or any combination thereof (para [0022], sampling unit an elongate rod made of rigid plastic material.).
In regards to claim 8, Tomer and Bogart disclose the limitations of claim 1. Tomer further shows that the stem is configured to provide: mechanical support for the absorptive component of the swab (para [0022], sampling unit an elongate rod made of rigid plastic material.); but does not specifically disclose capillary flow through a porous core of the stem. However, Tomer discloses capillary flow from the absorptive component of the swab to a sample receiving portion of the test strip (Figs. 1 A, 3A, 4A, 4B, 5; para [0021], [0022], fluid solution, 52, that is a reagent for extraction... strip unit, 20, with sample wick, 28, and conjugate pad, 30, for directing and aiding capillary action advancement of the analyzed liquid to the test strip.). To a person of ordinary skill in the art before the filing date of the claimed invention, it would have been obvious through routine experimentation to select amongst known swab mechanical supports such as paper in order to optimize the capillary flow of the sample.
In regards to claim 9, Tomer and Bogart disclose the limitations of claim 1. Tomer further discloses wherein the absorptive component of the swab is composed of a fiber (para [0022], fibrous swab.), foam of polymeric material, absorbent material, or any combination thereof.
In regards to claim 10, Tomer and Bogart disclose the limitations of claim 5. Bogart further discloses that the acidic non-volatile reagent is deposited at the absorptive component of the swab by: spraying, dipping, or dispersing the solvent containing the acidic non-volatile reagent (col 6, ln 37-44; col 8, ln 66 to col 9, ln 26, spincoating.); but does not specifically disclose said agent is deposited the absorptive component of the swab, and evaporating the solvent. To a person of ordinary skill in the art before the filing date of the claimed invention, it would have been obvious through routine experimentation to select amongst methods of coating and evaporating a non-volatile reagent for preparing and preserving a sterile swab device (para [0007]).
In regards to claim 11, Tomer and Bogart disclose the limitations of claim 5. Bogart further discloses that the amount of the acidic non-volatile reagent is between 2 and 800 micromoles (col 11, ln 49-59; acetic acid at 0.5M or about 500 micromoles.).
In regards to claim 12, Tomer and Bogart disclose the limitations of claim 5. Bogart further discloses that the acidic non-volatile reagent is soluble in the extraction reagent (col 11, ln 49-59; nitric acid and acetic acid extraction.).
In regards to claim 13, Tomer and Bogart disclose the limitations of claim 5. Bogart further discloses that the acidic non-volatile reagent is insoluble in the extraction reagent (col 6, ln 60 to col 7, ln 6; col 7, ln 48-50).
In regards to claim 14, Tomer and Bogart disclose the limitations of claim 5. Bogart further discloses that the acidic non-volatile reagent is configured to exchange protons with the extraction reagent (col 7, ln 43-48; col 10, ln 50-54; relative extraction done with nitrous acid and strong base.).
In regards to claim 15, Tomer and Bogart disclose the limitations of claim 13. Bogart further discloses that the insoluble acidic non-volatile reagent is deposited in a region configured to attach to the absorptive component (col 6, ln 37-44; col 8, ln 66 to col 9, ln 26, spincoating.); but does not specifically disclose said reagent deposited on the swab and wherein the insoluble acidic non-volatile reagent is deposited on the swab by coating with a membrane or film made of a polymeric material prior to the application of the absorptive component, so as to result in avoiding direct contact between the acid and the subject. However, Tomer further discloses impregnating a pad with a reagent (para [0029]). To a person of ordinary skill in the art, before the filing date of the claimed invention, it would have been obvious through routine experimentation to select amongst methods of coating active reagents for use with medical subjects in order to optimize the safe and sterile use of the swab device (para [0036]).
In regards to claim 16, Tomer and Bogart disclose the limitations of claim 5. Bogart further discloses that the acidic non-volatile reagent is organic (col 3, ln 63-65, citric acid.).
In regards to claim 17, Tomer and Bogart disclose the limitations of claim 5. Bogart further discloses that the acidic non-volatile reagent is inorganic (col 3, ln 63-65, nitric acid.).
In regard to claim 18, Tomer and Bogart disclose the limitations of claim 1. Tomer further discloses that the device comprises:
a first structural component configured to attach the absorptive component of the swab by the stem of the swab (Fig. 1 A; para [0024], separator, 16, retains sampling unit, 11, and sampling element, 38, separate from fluid solution, 52, wherein the sampling element swab is attached to the sampling unit rod.),
a second structural component configured to house the test strip (Figs. 1A, 4B, 5; para [0024], separator, 18, defines zone, 17, within housing, 12, for strip unit, 20 and film foil, 26, covering receptacle for fluid solution.),
wherein the absorptive component and a sample receiving portion of the test strip are in liquid communication when joining the first structural component and the second structural component (Figs. 4B, 5; para [0024], film foil, 26, penetrated by sampling unit and element when swab is inserted into the fluid solution, 52.).
In regards to claim 19, Tomer discloses a method, comprising:
(i) collecting a biological sample of a subject by use of a swab (Figs. 1A, 3A, 3B; para [0021], [0022], sampling unit, 11, with sampling element, 36... swab.);
(ii) transferring the swab to a chamber containing an extraction reagent (Figs. 1A, 3A, 3B, 5; para [0021], [0022], sampling element, 36... clipped in fluid solution, 52, that is a reagent for extraction.);
(iii) extracting an analyte from the biological sample of the subject by the extraction solution (para [0025], sample from a surface such as a vaginal surface.);
(iv) contacting the extraction solution containing the extracted analyte with a lateral flow immunochromatographic assay device comprising a labeled analyte-specific reagent (Figs. 1A, 3A, 4A, 4B, 5; para [0021], [0022], fluid solution, 52, that is a reagent for extraction... strip unit, 20, with sample wick, 28, for directing and aiding capillary action advancement of the analyzed liquid to the test strip.); and
(v) determining a presence or absence of the extracted analyte in the biological sample of the subject, wherein the binding of the analyte to a capture reagent specifically immobilizes the labeled analyte-indicator complex on the lateral flow immunochromatographic assay device (Fig. 3B; para [0006], [0023], [0034], lateral flow membrane, 22, with analysis results at line, 46, and control, 44... positive result resulted in red line and a negative result did not result in any red line... with antigen immobilized as a line captures the complex ), and wherein the capture reagent is configured to specifically bind to the analyte (para [0006], [0034], signal reagent binds to the antigen or antibody in the sample and moves through the membrane by capillary action... for test positive a pink/purple/red line develops.).
However, Toner does not specifically disclose the following:
in (i) said swab comprising a first, nonvolatile reagent; and
in (ii) so as to allow the non-volatile reagent to react with the extraction reagent and result in generating an extraction solution.
However, Bogart discloses sampling of an analyte for extraction using a non-volatile reagent (col 2, ln 37-54; col 3, ln 57-65; col 6, ln 37-44; col 9, ln 17-26; extraction and detection of antigens using acid reagent and nitrite salt... with a coated binding surface.) and the nonvolatile reagent to react with the extraction reagent and result in generating an extraction solution (col 7, ln 43-48; col 10, ln 50-54; col 11, ln 49-59; nitric acid and acetic acid extraction... relative extraction done with nitrous acid and strong base.).
To a person of ordinary skill in the art before the filing date of the claimed invention, it would have been obvious to substitute a non-volatile reagent as taught by Bogart for use in the swab device as in Tomer in order to test for desired microorganisms such as Streptococci (col 2, ln 55-63; col 4, ln 33-40), because Tomer and Bogart are directed towards swab extraction devices for use with mucus and vaginal surfaces (col 2, ln 1-15; col 10, ln 33-49).
In regards to claim 20, Tomer discloses a method comprising:
(i) collecting a biological sample of a subject (para [0025], sample from a surface such as a vaginal surface.) by an absorptive component of a swab (Figs. 1 A, 3A, 3B; para [0021], [0022], sampling unit, 11, with sampling element, 36... swab.), wherein the absorptive component of the swab is configured to be in physical contact with a sample receiving portion of a lateral flow immunochromatographic assay test strip comprising a labeled analyte-specific reagent (Figs. 1A, 3A, 4A, 4B, 5; para [0021], [0022], fluid solution, 52, that is a reagent for extraction... strip unit, 20, with sample wick, 28, for directing and aiding capillary action advancement of the analyzed liquid to the test strip.);
(ii) transferring the absorptive component of the swab to a chamber containing an extraction reagent, and wherein the extraction solution is configured to extract the biological sample of the subject (Figs. 1 A, 3A, 3B, 5; para [0021], [0022], sampling element, 36... dipped in fluid solution, 52, that is a reagent for extraction for a sample.);
(iii) extracting an analyte from the biological sample (para [0012], [0025]);
(iv) determining the presence or absence of the extracted analyte in the biological sample of the subject by measuring a signal generated by a binding of a labeled analyte-indicator complex to a capture reagent (para [0006], [0034], signal reagent binds to the antigen or antibody in the sample and moves through the membrane by capillary action... for test positive a pink/purple/red line develops.), wherein the capture reagent is immobilized on the lateral flow immunochromatographic assay device (Fig. 3B; para [0006], [0023], [0034], lateral flow membrane, 22, with analysis results at line, 46, and control, 44... positive result resulted in red line and a negative result did not result in any red line... with antigen immobilized as a line captures the complex.), and
wherein the capture reagent is configured to specifically bind the analyte (para [0006], [0034], signal reagent binds to the antigen or antibody in the sample and moves through the membrane by capillary action... for test positive a pink/purple/red line develops.).
Tomer does not specifically disclose in (ii) an extraction solution is formed in-situ by the reaction of the extraction reagent with the second non -volatile reagent incorporated in the absorptive component of the swab.
However, Bogart discloses sampling of an analyte for extraction using a non-volatile reagent (col 2, ln 37-54; col 3, ln 57-65; col 6, ln 37-44; col 9, ln 17-26; extraction and detection of antigens using acid reagent and nitrite salt... with a coated binding surface.) and an extraction solution is formed in-situ by the reaction of the extraction reagent with the second non-volatile reagent (col 7, ln 43-48; col 10, ln 50-54; col 11, ln 49-59; nitric acid and acetic acid extraction... relative extraction done with nitrous acid and strong base.) incorporated in the absorptive component surface (col 6, ln 37-44; col 8, ln 66 to col 9, ln 26, spincoating.).
To a person of ordinary skill in the art before the filing date of the claimed invention, it would have been obvious to substitute a non-volatile reagent as taught by Bogart for use in the swab device as in Tomer in order to test for desired microorganisms such as Streptococci (col 2, ln 55-63; col 4, ln 33-40), because Tomer and Bogart are directed towards swab extraction devices for use with mucus and vaginal surfaces (col 2, ln 1-15; col 10, ln 33-49).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSHUA DARYL DEANON LANNU whose telephone number is (571)270-1986. The examiner can normally be reached Monday-Thursday 8 AM - 5 PM, Friday 8 AM -12 PM.
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/JOSHUA DARYL D LANNU/Examiner, Art Unit 3791
/CARRIE R DORNA/Primary Examiner, Art Unit 3791