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 .
Response to Arguments
Applicant's amendments and arguments, filed 7/23/2026, regarding the rejection of claims 1 – 6 under 35 U.S.C. 103 as being unpatentable over Hudak et al. (US 2002/0173047 A1) in view of Saunders (US 3,925,018), have been fully considered and are persuasive. Therefore, this rejection has been withdrawn. Furthermore, the previous prior art rejections have been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in further in view of England (US 2007/0087444 A1), Lye et al. (WO 2005/059162 A2), Carpenter et al. (US 2002/0121235 A1) and Genovese et al. (US 2014/0065030 A1).
The previous rejections of claims 1 – 6 and 8 – 12 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, have been withdrawn.
The previous rejections of claims 8 – 12 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, have been withdrawn.
The previous objection to claim 5 has been withdrawn.
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 – 6 and 8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 11 of U.S. Patent No. 10,942,126 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because they are coextensive in scope and essentially claiming the same invention.
Note Regarding Prior Art
Examiner cites particular sections, columns, line numbers, paragraphs and figures, in the references as applied to the claims below for the convenience of the Applicant. Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the Applicant fully consider the references in their entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the Examiner.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 1 – 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hudak et al. (US 2002/0173047 A1; hereinafter “Hudak”) in view of Saunders (US 3,925,018; hereinafter “Saunders”), England (US 2007/0087444 A1; hereinafter “England”), Lye et al. (WO 2005/059162 A2; hereinafter “Lye”), Carpenter et al. (US 2002/0121235 A1; hereinafter “Carpenter”) and Genovese et al. (US 2014/0065030 A1; hereinafter “Genovese”).
Regarding claim 1, Hudak teaches a system for identifying the presence of a target molecule or ion (e.g., paragraphs 25, 31, 34 and 43 – 80; figures 1 – 3), comprising:
a solid support (test platform 2 including test strip 3; figure 1); and
a dry chemical reagent (the area covered by sample receiving chamber 1 into which the test sample is inserted; figure 1) on the solid support (test platform 2 including test strip 3) comprising a first chemical reagent (e.g., a specific binding member, indicator or substrate; paragraphs 25, 47, 84 – 88 and 104 – 106) and a dispersion reagent (e.g., a dispersant, stabilizer or diluent; paragraph 47) applied to the solid support, the first chemical reagent producing a presumptive color indication that identifies or excludes the presence of the first target molecule or ion (paragraphs 105 and 109). Hudak does teach that additional or secondary reagents can be incorporated with their disclosed system, and including multiple detection zones (e.g., one or more detection zones 9; paragraphs 62, 63, 67, 70, 72, 73, 83, 96 and 103 – 105; e.g., one or more reagent zones 32; paragraph 119; figures 8 and 9).
Hudak does not specifically teach that the chemical reagents can be micronized. However, Saunders teaches the use of typical analytical chemistry reagent particle sizes of 5 to 15 microns (e.g., col. 3, line 29 – col. 4, line 66). These particle reagents are useful in colorimetric reactions (col. 10, lines 3 – 9). The selection of a known material, which is based upon its suitability for the intended use, is within the ambit of one of ordinary skill in the art (see MPEP § 2144.07). The combination of familiar elements is likely to be obvious when it does no more than yield predictable results (see MPEP § 2143, A.). Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to provide that the first chemical reagent comprises a micronized powder or is in the form of a micronized powder.
Hudak does not specifically teach a plurality of dry chemical reagents on the solid support, wherein a first chemical reagent comprises a first dry micronized chemical reagent and the dispersion reagent, wherein the first dry micronized chemical reagent comprises cresol red. However, England teaches the use of a cresol red as an indicating composition for detection (e.g., pH indicator for dissolved hydrogen ion; paragraph 13). The selection of a known material, which is based upon its suitability for the intended use, is within the ambit of one of ordinary skill in the art (see MPEP § 2144.07). The combination of familiar elements is likely to be obvious when it does no more than yield predictable results (see MPEP § 2143, A.). Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to provide that the chemical reagent is a cresol red to facilitate effective target dissolved hydrogen ion molecule detection.
Hudak does not specifically teach a plurality of dry chemical reagents on the solid support, wherein a second dry micronized chemical reagent comprises a second dry micronized chemical reagent and the dispersion reagent, wherein the second dry micronized chemical reagent comprises merocyanine dye. However, Lye teaches the use of a merocyanine dye as an indicating composition for detection (page 4). The selection of a known material, which is based upon its suitability for the intended use, is within the ambit of one of ordinary skill in the art (see MPEP § 2144.07). The combination of familiar elements is likely to be obvious when it does no more than yield predictable results (see MPEP § 2143, A.). Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to provide that the chemical reagent is a merocyanine dye to facilitate effective target molecule detection.
Hudak does not specifically teach a plurality of dry chemical reagents on the solid support, wherein a third dry chemical reagent comprises a third dry micronized chemical reagent and the dispersion reagent, wherein the third dry micronized chemical reagent comprises potassium iodide. However, Carpenter teaches the known use of potassium iodide as an indicator for detection applications (paragraph 19). The selection of a known material, which is based upon its suitability for the intended use, is within the ambit of one of ordinary skill in the art (see MPEP § 2144.07). The combination of familiar elements is likely to be obvious when it does no more than yield predictable results (see MPEP § 2143, A.). Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to provide that the chemical reagent is potassium iodide to facilitate effective target molecule detection.
Hudak does not specifically teach a plurality of dry chemical reagents on the solid support, wherein a fourth dry chemical reagent comprises a fourth dry micronized chemical reagent and the dispersion reagent, wherein the fourth dry micronized chemical reagent comprises diphenylamine. However, Genovese teaches the known use of diphenylamine as an indicator for nitrate detection applications (paragraph 26). The selection of a known material, which is based upon its suitability for the intended use, is within the ambit of one of ordinary skill in the art (see MPEP § 2144.07). The combination of familiar elements is likely to be obvious when it does no more than yield predictable results (see MPEP § 2143, A.). Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to provide that the chemical reagent is diphenylamine to facilitate effective target nitrate molecule detection.
Regarding claim 2, Hudak does teach that the plurality of dry chemical reagents can be spaced apart from one another by a physical gap (e.g., via one or more analyte detection zones 9; paragraphs 62, 63, 67, 70, 72, 73, 76, 83, 96, 103 – 105 and 115; figures 8 and 9; e.g., one or more reagent zones 32; paragraph 119).
Regarding claim 3, Hudak teaches the system of claim 1, wherein the solid support comprises a material selected from the group consisting of glass, metal, paper, organic membranes (e.g., test strip 3 can comprise glass fiber, nitrocellulose membrane sheets, filter paper, nylon or polyester materials; paragraphs 46, 79 and 80; the test platform 2 can comprise glass, ceramic metals, paper or polymers; paragraph 68).
Regarding clams 4 and 5, Hudak teaches that the system further comprises a sample collector (swab 4 which is implicitly comprised of an unreactive adsorbent fiber so as to not react with the sample under analysis; paragraph 48; figure 1) for collection of an unknown molecule or ion and introducing the unknown molecule or ion to the first chemical reagent.
Regarding claim 6, Hudak teaches the system of claim 1, further comprising a moisture and UV resistant package in which the solid support and first chemical reagent is sealed (e.g., the disclose system can be prepackaged with a barrier, such as foils and plastics. to protect and preserve the contents for future use; it is considered implicit that the packaging material would be moisture and UV resistant barrier materials; paragraphs 26 and 55 – 57).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hudak et al. (US 2002/0173047 A1; hereinafter “Hudak”) in view of Saunders (US 3,925,018; hereinafter “Saunders”), England (US 2007/0087444 A1; hereinafter “England”), Lye et al. (WO 2005/059162 A2; hereinafter “Lye”), Carpenter et al. (US 2002/0121235 A1; hereinafter “Carpenter”) and Genovese et al. (US 2014/0065030 A1; hereinafter “Genovese”), as applied to claims 1 – 6 above, and further in view of Cincotta et al. (US 2014/0366796 A1; hereinafter “Cincotta”).
Regarding claim 8, modified Hudak does not specifically teach the system of claim 1, wherein the dispersion reagent is selected from the group consisting of acrylic acid, polyvinyl alcohol, amino crosslinkers, polyvinyl pyrollidinone, glycol-ethers, styrene, polyester, vinyl chloride, polyethylene, natural gums, polyether and polyamide units. However, Cincotta teaches the use of a dispersant comprising acrylic acid for use in colorant indicator compositions (paragraph 46). These dispersants are effective and useful in reagent compositions for colorimetric applications (Abstract). The selection of a known material, which is based upon its suitability for the intended use, is within the ambit of one of ordinary skill in the art (see MPEP § 2144.07). The combination of familiar elements is likely to be obvious when it does no more than yield predictable results (see MPEP § 2143, A.). Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to provide wherein the dispersant is acrylic acid.
Conclusion
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 BRIAN J. SINES whose telephone number is (571)272-1263. The examiner can normally be reached 9 AM-5 PM EST M-F.
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, Lyle Alexander can be reached at (571) 272-1254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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BRIAN J. SINES
Primary Patent Examiner
Art Unit 1796
/BRIAN J. SINES/Primary Examiner, Art Unit 1796
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