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 .
The claims filed 1/14/2026 are under consideration.
The amendments and arguments presented in the papers filed 1/14/2026 ("Remarks”) have been thoroughly considered. The issues raised in the Office action dated 7/14/2025 listed below have been reconsidered as indicated.
a) Any objections or rejections of claims 2 and 11 are rendered moot by the cancellation of the claims.
b) The objections of claims 1, 10 and 19 are withdrawn in view of the amendments to the claims.
c) The rejections of claims 1-8 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, are withdrawn in view of the amendments to the claims.
d) The rejections of claim(s) 9 and 12-16 under 35 U.S.C. 103 as being unpatentable over Whitney (US 2013/0209997 A1) are withdrawn in view of the amendments to the claims.
The Examiner’s responses to the Remarks regarding issues not listed above are detailed below in this Office action.
New and modified grounds of rejection necessitated by amendment are detailed below and this action is made FINAL.
Election/Restrictions
The restriction requirement between Groups I and II was withdrawn.
In view of the above noted withdrawal of the restriction requirement, applicant is advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application.
Once a restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Information Disclosure Statement
The listing of references in the specification or the citation of references throughout the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892 or cited on a submitted IDS, they have not been considered.
Drawings
High resolution copies of the drawings may be accessed via PAIR/Patent Center Retrieval using the Supplemental Content tab.
Claim Rejections - 35 USC § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 17 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Fischer (US 2014/0038174 A1; previously cited).
The following rejection has been maintained.
Regarding claim 17, Fischer teaches a composition having: guanidine thiocyanate (e.g., a chaotropic agent); TRIS (e.g., a buffering agent); EDTA (e.g., a metal chelating agent); N-lauroyl sarcosine (e.g., a surfactant); ethanol (e.g., an alcohol); and TCEP (e.g., a mucolytic agent). See Table 1B.
Fischer further teaches the above composition is combined with one comprising N-acetyl-L-cysteine (NaLc) (para. 155) resulting in a composition with: guanidine thiocyanate; TRIS; EDTA; N-lauroyl sarcosine (e.g. a surfactant); ethanol and TCEP; and an additional mucolytic agent or reducing agent comprising NaLc.
The only components of the modified composition of Fischer resulting from the combining of the two solutions are those listed above. Thus, the composition of Fischer is devoid of antimicrobial agent(s), bactericidal agent(s), and/or bacteriostatic agent(s) other than the chaotropic agent, the detergent or surfactant, the alcohol, and the mucolytic agent or reducing agent as specified in claims 17.
Response to the traversal of the 102 rejections
The Remarks argue Fischer teaches, in para. 155, "the NaLc/NaOH procedure is used prior to culture methods and nucleic acid testing for M. tuberculosis. Aliquots of 0.5 mL of the NaCl/NaOH treated sputum samples were then added to PrimeStore® and stored overnight." and therefore Fischer teaches combining "NaCl" samples with the PrimeStore® composition; not "NaLc" samples (p. 2 of 4).
The arguments have been fully considered but are not persuasive. It is the examiner’s position that the reference to “NaCl” treated samples is a typographical error. First, it is noted that the mention of “NaCl” is only in para. 155 of the references and there are mentions of it or to “sodium chloride” any place else. Second, the mention of “the NaCl/NaOH treated sputum” is understood to be referring to a previous sample that is described as being treated in para. 155. The only mention of treating sputum in para. 155 is treating “raw sputum” with “NaLc/NaOH”. Third, Fischer repeatedly describes throughout the reference treating sputum with “NaLc/NaOH”. See paras. 155, 157, 158, 159 and 184; and Table 11. Fourth, Fischer does not provide any details of how to treat a sputum sample with NaCl/NaOH. Taking the reference as a whole, one would recognize that Fischer is focused on using “NaLc/NaOH” treatment of sputum and not “NaCl/NaOH” treatment of sputum.
The state of the art demonstrates that the combination of treating sputum with NaLc/NaOH and Primestore was a known process as compared to treating sputum with NaCl/NaOH. See Daum (Int J Tuberc Lung Dis. 2016. 20(8):1118-1124; it is noted that the listed inventors on the Fischer reference, e.g., Fischer and Daum, are also co-authors on the Daum reference). Daum describes treating samples of M. tuberculosis in PS-MTM (i.e., Primestore®) with NALC/NaOH (p. 1119, NALC/NaOH-inactivated M. tuberculosis dilutions) and further states “The Xpert assay detected M. tuberculosis from NALC/NaOH pretreated PS-MTM samples” (p. 1120). In conclusion, when taking the reference as a whole and the state of the art, the ordinary artisan would appreciate that Fischer is describing the mixing of PrimeStore® with NaLc/NaOH treated sputum rather than “NaCl/NaOH” treated sputum.
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 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1, 3-10, 15-16 and 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fischer (US 2014/0038174 A1; previously cited) in view of Whitney (US 2013/0209997 A1).
The following are modified rejections of the claims.
Regarding claims 1, 3 and 9-10, Fischer teaches a composition “PRIMESTORE™” having: nuclease-free water (e.g., an aqueous carrier); guanidine thiocyanate (e.g., a chaotropic agent); TRIS (e.g., a buffering agent); EDTA (e.g., a chelating agent); N-lauroyl sarcosine (e.g., a surfactant); ethanol (e.g., an alcohol); and TCEP (e.g., a mucolytic agent). See Table 1B.
Fischer further teaches the acid is added qs to a pH of 6 to 7 and water is added qs to a final volume. Fischer further teaches the formulations that stabilize the nucleic acids have a pH of 6.0 to 9.5 (para. 77).
The following concentrations taught by Fischer are taken from Table 1B and have been converted by the Examiner from molar concentration to percentages.
Fischer teaches a concentration for a chaotropic agent of 0.5M to 6M, which is a percentage concentration of 5.91% to 70.90% (a range that overlaps with and spans the claimed range).
Fischer teaches a concentration for a buffering agent of 1mM to 1M, which is a percentage concentration of 1.21% to 12.11% (a range that overlaps with and spans the claimed range).
Fischer teaches a concentration for a chelating agent of 0.01mM to 1mM, which is a percentage concentration of 0.0004% to 0.0372%. A concentration of 0.0372% is near the claimed value of 0.05%. One would reasonably expect the concentration of the chelating agent to have a similar effect as the claimed concentration as the difference between 0.0372% and 0.05% is only 0.0128 percent.
Fischer teaches a concentration for a surfactant of 0.15% to 1% (a range that overlaps the claimed range).
Fischer teaches a concentration for an alcohol of 1% to 25% (a range that overlaps and spans the claimed range).
Fischer teaches a concentration for a mucolytic agent of 0.5 mM to 30 mM, which is a percentage concentration of 0.014% to 0.86% (a range that overlaps the claimed range).
Fischer further teaches combining sputum samples having N-acetyl-L-cysteine present with PrimeStore (i.e., the above described solution) (para. 155). This results in a new composition that comprises N-acetyl-L-cysteine as a mucolytic agent or reducing agent.
It would have been prima facie obvious to have either directly added the N-acetyl-L-cysteine to the “PrimeStore” solution or to have substituted N-acetyl-L-cysteine as the mucolytic or reducing agent to arrive at the claimed composition. One would have been motivated to do so because N-acetyl-L-cysteine has a known use as a decontaminator (Fischer, para. 155).
Fischer further teaches the solutions are for the preservation of DNA integrity within the sample (para. 101) and stabilizes liberated nucleic acids (DNA) (para. 65).
While Fischer teaches the broad range of pH values of 6.5 to 9.0, which overlaps with the present claimed range of 7.2-8.8, Fischer does not particularly focus on the pH range as claimed.
However, Whitney teaches compositions for stabilizing DNA in saliva.
Whitney teaches that pH values of solutions varies between use with RNA or DNA, with RNA being more acidic and DNA being more basic (para. 35). Whitney teaches solutions for stable DNA storage with pH values of 7.4, 7.8, 8.0, 8.2, 8.4, 8.6 and 8.8 (para. 35).
It would have been prima facie obvious to the ordinary artisan at the time of filing to modify the pH of the composition of Fischer to stabilize DNA within a sample, in particular in saliva. One would have been motivated to optimize the pH of the solution by trying the basic pH taught by Whitney for DNA stabilization. The modification has a reasonable expectation of success because adjusting the pH of a solution is a well understand practice for the optimization of a solution and Fischer teaches the pH of their compositions Fischer may have a pH of 6.0 to 9.5 (para. 77).
Regarding claims 4, 5 and 6, the only components of the composition of Fischer are those listed above. Thus, the composition of Fischer is devoid of:
antimicrobial agent(s), bactericidal agent(s), and/or bacteriostatic agent(s) other than the chaotropic agent, the detergent or surfactant, the alcohol, and the mucolytic agent or reducing agent;
protease(s); and/or
inhibitor(s) of ribonuclease other than the chaotropic agent, the surfactant, the alcohol, and the mucolytic agent,
as specified in claims 4, 5 and 6.
Regarding claims 7 and 15, Fischer teaches the composition is within a collection tube (para. 136) and one would recognize the solutions of para. 155 are within a tube, which is encompassed by the broad scope of a “sample collection apparatus” comprising a solution compartment in view of the instant specification (para. 106).
Regarding claims 8 and 16, Fischer teaches obtaining a biological sample and contacting the sample with the above composition (para. 136).
Regarding claims 12-14, the only components of the composition of Fischer are those listed above. Thus, the composition of Fischer is devoid of:
antimicrobial agent(s), bactericidal agent(s), and/or bacteriostatic agent(s) other than the chaotropic agent, the detergent or surfactant, the alcohol, and the mucolytic agent or reducing agent;
protease(s); and/or
inhibitor(s) of ribonuclease other than the chaotropic agent, the surfactant, the alcohol, and the mucolytic agent,
as specified in claims 12-14.
Regarding claims 18 and 20, Fischer teaches a composition having: guanidine thiocyanate (e.g. a chaotropic agent); TRIS (e.g. a buffering agent); EDTA (e.g. a metal chelating agent); N-lauroyl sarcosine (e.g. a surfactant); ethanol (e.g. an alcohol); and TCEP (e.g. a mucolytic agent). See Table 1B.
Fischer further teaches the above composition is combined with one comprising N-acetyl-L-cysteine (NaLc) (para. 155) resulting in a composition with: guanidine thiocyanate; TRIS; EDTA; N-lauroyl sarcosine (e.g. a surfactant); ethanol and TCEP; and an additional mucolytic agent or reducing agent comprising NaLc.
The only components of the modified composition of Fischer resulting from the combining of the two solutions are those listed above. Thus, the composition of Fischer is devoid of antimicrobial agent(s), bactericidal agent(s), and/or bacteriostatic agent(s) other than the chaotropic agent, the detergent or surfactant, the alcohol, and the mucolytic agent or reducing agent as specified in claims 17.
Fischer further teaches the acid is added qs to a pH of 6 to 7 and water is added qs to a final volume. Fischer further teaches the pH of the formulations that stabilize the nucleic acids is 6.0 to 9.5 (para. 77).
Fischer further teaches the solutions are for the preservation of DNA integrity within the sample (para. 101) and stabilizes liberated nucleic acids (DNA) (para. 65).
While Fischer teaches the broad range of pH values of 6.5 to 9.0, which overlaps with the present claimed range of 7.2-8.8, Fischer does not particular focus on this range.
However, Whitney teaches compositions for stabilizing DNA in saliva.
Whitney teaches that pH values of solutions varies between use with RNA or DNA, with RNA being more acidic and DNA being more basic (para. 35). Whitney teaches solutions for stable DNA storage with pH values of 7.4, 7.8, 8.0, 8.2, 8.4, 8.6 and 8.8 (para. 35).
It would have been prima facie obvious to the ordinary artisan at the time of filing to modify the pH of the composition of Fischer to stabilize DNA within a sample. One would have been motivated to optimize the pH of the solution by trying the basic pH taught by Whitney. The modification has a reasonable expectation of success because adjusting the pH of a solution is a well understand practice for the optimization of a solution.
Regarding claim 19, the only components of the modified composition of Fischer are those listed above. Thus, the composition of Fischer is devoid of the elements specified in claims 19.
Claim(s) 9 and 12-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Birnboim (US 2004/0038269 A1; previously cited).
The following are modified rejections necessitated by the amendments to the claims.
Regarding claim 9, Birnboim teaches aqueous solutions (para. 12 and 37). The solution comprises a chaotropic agent (urea), a buffering agent (TRIS-HCl), a chelating agent (CDTA), a detergent or surfactant (sodium dodecyl sulfate), an alcohol comprising ethanol and a mucolytic agent or reducing agent (sodium ascorbate). See para. 115.
Birnboim teaches the solution has a pH of 8 (para. 115).
While Birnboim does not teach the chaotropic agent comprises guanidine thiocyanate in the above composition, Birnboim also teaches the following.
Birnboim teaches the “denaturing agent” can be selected from the group consisting of: urea, dodecyl sulfate, guanidinium chloride, guanidinium thiocyanate, perchlorate, and an alcohol (para. 20).
Thus, Birnboim teaches that urea and guanidine thiocyanate are obvious variants of one another. It would have been prima facie obvious to have modified the above aqueous solution of Birnboim by simply substituting one known agent for another known agent that are specifically identified as being alternatives to one another.
While Birnboim does not teach the mucolytic agent or reducing agent is N-acetyl-L-cysteine in the above composition, Birnboim also teaches the following.
Birnboim teaches desirably, the reducing agent is ascorbic acid, erythiorbate, N-acetylcysteine, dithiothreitol, or 2-mercaptoethanol (para. 13).
Thus, Birnboim teaches that sodium ascorbate/ascorbic acid and , N-acetylcysteine are obvious variants of one another. It would have been prima facie obvious to have modified the above aqueous solution of Birnboim by simply substituting one reducing agent for another reducing agent that are specifically identified as being desirable alternatives.
Regarding claims 12-14, the only components of the composition of Birnboim are those listed above. Thus, the composition of Birnboim is devoid of:
antimicrobial agent(s), bactericidal agent(s), and/or bacteriostatic agent(s) other than the chaotropic agent, the detergent or surfactant, the alcohol, and the mucolytic agent or reducing agent;
protease(s); and/or
inhibitor(s) of ribonuclease other than the chaotropic agent, the surfactant, the alcohol, and the mucolytic agent,
as specified in claims 12-14.
Regarding claim 15, Birnboim teaches mixing the above composition with an equal volume of saliva (para. 115). One would recognize that these solutions, e.g., the aqueous solution or the saliva or the mixture, are within a “solution compartment”, e.g., a tube, a well, etc.
Regarding claim 16, Birnboim teaches mixing the above composition with an equal volume of saliva (para. 115).
Regarding claim 17, Birnboim teaches aqueous solutions (para. 12 and 37). The solution comprises a chaotropic agent (urea), a buffering agent (TRIS-HCl), a chelating agent (CDTA), a detergent or surfactant (sodium dodecyl sulfate), an alcohol comprising ethanol (ethanol) and a mucolytic agent or reducing agent (sodium ascorbate). See para. 115.
While Birnboim does not teach the mucolytic agent or reducing agent is N-acetyl-L-cysteine in the above composition, Birnboim also teaches the following.
Birnboim teaches desirably, the reducing agent is ascorbic acid, erythiorbate, N-acetylcysteine, dithiothreitol, or 2-mercaptoethanol (para. 13).
Thus, Birnboim teaches that sodium ascorbate/ascorbic acid and , N-acetylcysteine are obvious variants of one another. It would have been prima facie obvious to have modified the above aqueous solution of Birnboim by simply substituting one reducing agent for another reducing agent that are specifically identified as being desirable alternatives.
The only components of the modified composition of Birnboim are those listed above. Thus, the composition of Birnboim is devoid of antimicrobial agent(s), bactericidal agent(s), and/or bacteriostatic agent(s) other than the chaotropic agent, the detergent or surfactant, the alcohol, and the mucolytic agent or reducing agent as specified in claims 17.
Regarding claim 18, Birnboim teaches the solution has a pH of 8 (para. 115).
Regarding claims 19, the only components of the composition of Birnboim are those listed above. Thus, the composition of Birnboim is devoid of:
protease(s); and
inhibitor(s) of ribonuclease other than the chaotropic agent, the surfactant, the alcohol, and the mucolytic agent,
as specified in claim 19.
Claim(s) 17-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Whitney (US 2013/0209997 A1) in view of Birnboim (US 2004/0038269 A1; previously cited).
The following are modified rejections.
Regarding claims 17-18, Whitney teaches a composition in claim 12. The composition comprises: a surfactant or a detergent (claim 12); a chelating agent, a reducing agent, a pH buffer, and water (claim 2); and, at least one lower alcohol, and at least one chaotrope (claim 1).
Claim 12 does not specifically identify what the reducing agent is; however, claim 10 identifies 2-mercaptoethanol, dithiothreitol or dithioerythritol as a reducing agent.
Claim 12 does not specify the pH of the composition. However, Whitney teaches that pH values of solutions varies between use with RNA or DNA, with RNA being more acidic and DNA being more basic (para. 35). Whitney teaches solutions for stable DNA storage with pH values of 7.4, 7.8, 8.0, 8.2, 8.4, 8.6 and 8.8 (para. 35). This element is thereby rendered obvious.
Whitney does not teach N-acetyl-L-cysteine as a reducing agent.
However, Birnboim teaches aqueous solutions (para. 12 and 37) that are analogous to Whitney as both are used to preserve samples. Similarly, to Whitney, Birnboim teaches the solution has a pH of 8 (para. 115).
Birnboim teaches desirably, the reducing agent is ascorbic acid, erythiorbate, N-acetylcysteine, dithiothreitol, or 2-mercaptoethanol (para. 13).
Thus, Birnboim teaches that 2-mercaptoethanol, dithiothreitol or dithioerythritol and N-acetylcysteine are obvious variants of one another. It would have been prima facie obvious to have modified the above aqueous solution of Whitney by simply substituting one reducing agent for another reducing agent that are specifically identified as being desirable alternatives.
Regarding claim 19, the only components of the composition of Whitney are those listed above. Thus, the composition of Whitney is devoid of:
antimicrobial agent(s), bactericidal agent(s), and/or bacteriostatic agent(s) other than the chaotropic agent, the detergent or surfactant, the alcohol, and the mucolytic agent or reducing agent;
protease(s); and/or
inhibitor(s) of ribonuclease other than the chaotropic agent, the surfactant, the alcohol, and the mucolytic agent,
as specified in claim 19.
Response to the traversal of the 103 rejections
The Remarks argue Fischer fails to teach incorporating N-acetyl-L-cysteine into a composition and Whitney and Birnboim fail to cure this deficiency (p. 2 and 3 of 4).
The arguments have been fully considered but are not persuasive. Fischer is not considered deficient for the reasons detailed above discussing the traversal of the 102 rejections.
Birnboim clearly suggests N-acetyl-L-cysteine as a “reducing agent” in para. 13. The Remarks fail to address this teaching of Birnboim.
Conclusion
No claims allowed.
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 JOSEPH G DAUNER whose telephone number is (571)270-3574. The examiner can normally be reached 7 am EST to 4:30 EST with second Fridays Off.
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/JOSEPH G. DAUNER/Primary Examiner, Art Unit 1682