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 .
Election/Restrictions
Applicant’s election of fentanyl and powder in the reply filed on December 1, 2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
The requirement is still deemed proper and is therefore made FINAL.
After further search and consideration, the species election requirement relating to the form of the drug compound has been withdrawn.
Priority
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. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 16/894,853, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. There is no disclosure in the prior filed US’853 application of the use of the disclosed compositions in the method as recited in the instant claims of neutralizing narcotic or opioid compounds.
The instant application is correctly identified as a continuation-in-part of the US’853 application.
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. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 63/460,436, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. There is no disclosure in the prior filed US’436 for the lower limit of the claimed quaternary ammonium compound of 2,000 ppm as required by independent claim 1. There is also no disclosure of an open ended range of at least 1,000 ppm for the chlorite salt recited in independent claim 15.
If Applicant is in disagreement with the Examiner regarding support for priority, Applicant is respectfully requested to point to page and line number wherein support may be found for the instant invention in one or both of the above mentioned applications.
In view of the above, the effective filing date of all claims of the instant application is April 19, 2024.
Drawings
The drawings are objected to because in figures 9 – 12 there are numerous misspellings of the word “heroin”. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities: trade names or marks used in commerce are present but are not properly formatted.
The use of the terms STEPAN BTC® and TOMADOL® 900, which are trade names or marks used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM, or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Appropriate correction is required.
Claim Rejections - 35 USC § 112 – Scope of Enablement
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 15 – 18 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for the neutralization of a drug from the Markush group of claim 15 when chloride dioxide is present in the composition used in the claimed method, does not reasonably provide enablement for neutralization of a drug from the Markush group of claim 15 when no chloride dioxide is present in the composition. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
The disclosure and claims of the application have been compared per the factors indicated in the decision In re Wands, 8 USPQ2nd 1400 (Fed. Cir. 1988) as to undue experimentation
The factors include:
1. The nature of the invention;
2. The breadth of the claims;
3. The predictability or unpredictability of the art;
4. The amount of direction or guidance presented;
5. The presence or absence of working examples
6. The quantity of experimentation necessary;
7. The state of the prior art; and
8. The relative skill of those skilled in the art.
Each relevant factor is addressed below on the basis of comparison of the disclosure, the claims and the state of the art in the assessment of undue experimentation.
The nature of the invention; the breadth of the claims:
The claims are drawn to a method in which a composition comprising a chlorite salt and at least one quaternary ammonium salt in particular concentration ranges is applied to a composition containing a drug compound to neutralize the drug compound. The preambles of independent claims 1 and 15 limit the drug to certain classes of drugs or specific compounds such as methamphetamine or cocaine.
The predictability or unpredictability of the art; the amount of direction or guidance presented; the presence or absence of working examples; the quantity of experimentation necessary; the state of the prior art; the relative skill of those skilled in the art:
As set forth in greater detail in the art rejections below, the general methodology of oxidizing drugs using oxidizing solutions such as those containing chlorine dioxide or chlorite to oxidize opioids to decontaminate or neutralize them is known in the art.
The specification sets forth examples with three drugs – fentanyl, heroin and xylazine that shows upon addition of a composition, whose ingredients and amounts of those ingredients are not given, new peaks appear in NMR spectra that are interpreted as showing neutralization of the drug (examples 4 – 6 and figures 6 – 16). Given this omission, the examples in the specification provide no information as to the reaction(s) occurring that result in changes in the NMR spectra and if such changes appeared for compositions containing no chlorine dioxide.
The active species that oxidizes material as the basis for the decontamination/neutralization of the drugs is chlorine dioxide, a potent oxidizer and the main purpose of chlorite is to generate sodium chloride when activated (p 3 of “The Science Behind Sodium Chlorite” from biltchem.com, accessed March 12, 2026). The chemical reactivity of chlorine dioxide differs markedly from other oxidants such as chlorine (p 2, col 1, ¶ 3 of “Sodium Chlorite Chlorine Dioxide Treatment for Industrial & Municipal Pollutants, August 2022) and “selective reactivity makes chlorine dioxide useful in many of the water and air treatment applications for which chlorine and other oxidizing agents are unsuitable” (p 1, col 1, ¶ 1).
One of ordinary skill in the art, such as a research scientist studying oxidation reactions, would understand that chlorite acts as the source of the active oxidant chlorine dioxide and that it is chlorine dioxide that reacts with drug substances such as opioids to bring about decontamination/neutralization of the opioid substances and not a direct reaction between the chlorite and narcotic/opioid. When the presence of chlorine dioxide is excluded from the composition used to neutralize the opioids, the necessary chemical reaction(s) cannot occur and the method is not enabled. Therefore the full scope of claim 15 and the claims that depend from claim 15 is not enabled.
Claim Rejections - 35 USC § 112 – Indefiniteness
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 15 - 18 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 15 requires “substantially no chlorine dioxide is present in solution” and the metes and bounds of this limitation cannot be determined. The word “substantially” in two different contexts is defined at ¶¶ [0055] and [0056] of the PGPub of the instant application but neither context relates to the permitted amounts of chlorine dioxide encompassed by the claim limitation of “substantially no chlorine dioxide”. Such phrasing encompasses some level of chlorine dioxide but what level results in a composition that is no longer within the scope of claim 15 as not been sufficiently set forth.
The dependent claims fall therewith.
Please clarify.
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.
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 – 10 and 15 – 18 are rejected under 35 U.S.C. 103 as being unpatentable over Bell et al. (US 11,090,520) in view of Stas et al. (US 2020/0108286), Zakharova et al. (Organic Materials as Smart Nanocarriers for Drug Delivery, 2018) and Politopoulos et al. (US 2021/0000107).
Bell et al. discloses a composition for the decontamination, which reads on neutralization, of opioids on surfaces or object, fentanyl in particular, using a mixture of an opioid-active reagent and an opioid-effective solubilizing agent which is a mixture of alkyl dimethylamine oxide surfactant, a C8-18 alkyl polyethylene glycol sorbitan fatty ester surfactant and a C12-14 secondary alcohol ethoxylate surfactant (whole document, e.g., abstract). The opioid-active reagent can be chlorine dioxide or a chlorine dioxide precursor such as sodium chlorite (col 1, ln 65 – col 2, ln 6; col 6, ln 13 - 14). Opioid-effective solubilizing agents are surfactants or detergents suitable for removing opioids from surfaces while also providing the ability to retain the opioid in water and prevent redeposition on the surface or other surfaces (col 4, ln 44 onwards). Compounds to adjust the pH to increase opioid water solubility by protonating the opioid can also be added as quaternary ammonium salts may increase water solubility (col 4, ln 63 – col 5, ln 8). Increased water solubility also improves the chemical interaction between the opioid and the water-soluble opioid-active agent that can increase the decontamination reaction rate (col 5, ln 4 – 8). As discussed in examples 1 and 2, the amount of the opioid-effective solubilizing agent and opiod-active regent in the composition is selected to provide a particular excess over the amount of opioid (col 6, ln 58 – col 7, ln 14).
Absolute concentration of the reagents and the presence of a quaternary ammonium salt is not disclosed.
Stas et al. discloses compositions for decomposing pharmaceutically active agents comprising up to 30 wt% oxidizer and up to 30 wt % immobilizer (whole document, e.g., abstract). Opioids can lead to accidental death, overdose, and dependency while also finding their way into the environment and drinking water (¶ [0003]). The compositions provide a way to safely dispose of unwanted or unused medications (¶ [0006]). The controlled substance can be in the form of tablets, capsules, powders, liquid or any other commonly known form that can be added directly to the composition or forms such as tablets or capsules can be crushed or broken prior to addition to the composition that will decompose the pharmaceutical active (¶ [0061]).
Zakharova et al. discloses that quaternary ammonium compounds demonstrate enhanced capacity for drug solubilization compared to their neutral counterparts (abstract).
Politopoulos et al. discloses compositions for antimicrobial use that comprise about 2,000 ppm to about 8,000 ppm chlorite salt and/or chlorine dioxide and about 5,000 ppm to about 10,000 ppm of at least one quaternary ammonium salt (whole document, e.g., abstract). The quaternary ammonium salts recited at ¶ [0012] are quaternary ammonium surfactants. The compositions can be used on a hard or soft surface or with a product (¶ [0022]).
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to use a composition comprising chlorite and a quaternary ammonium salt to decontaminate opioid compounds whether present on a surface as in Bell et al. or in a pharmaceutical dosage form as in Stas et al. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because oxidizing compositions such as those comprising chlorite are taught in the art for the decontamination/neutralization of opioid containing compositions. Bell et al. discloses that increased water solubility also improves the chemical interaction between the opioid and the water-soluble options-active agent that can increase the decontamination reaction rate and the presence of quaternary ammonium surfactants such as those disclosed by Politopoulos et al. would reasonably be expected to enhance opioid solubility regardless of the salt form of the opioid present on the surface or dosage form. The amount of the active and solubilizing ingredients would be routinely optimized by one of ordinary skill in the art and overlapping ranges are prima facie obviousness (see MPEP 2144.05). Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient to add in order to best achieve the desired results of drug decontamination and solubilization.
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 – 10 and 14 – 18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 7, 9 – 11, 13 – 17, 21, 22, and 25 of copending Application No. 17/143,148 in view of Bell et al. (US 11,090,520), Stas et al. (US 2020/0108286), and Zakharova et al. (Organic Materials as Smart Nanocarriers for Drug Delivery, 2018). The claims of US’148 recite an antimicrobial composition comprising about 2,000 to about 8,000 ppm chlorite salt, about 5,000 to about 10,000 ppm of at least one quaternary ammonium compound and about 8,000 to about 15,000 ppm sodium tetraborate (claim 1).
Bell et al., Stas et al. and Zakharova et al. are discussed above.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate a quaternary ammonium surfactant into the composition of US’148 and to then use the resulting composition to neutralize opioids that are present on a surface or in a dosage form. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because Bell et al. discloses that chlorine dioxide containing solutions such as those made with the precursor chlorite can decontaminate/neutralize opioids on surfaces and Stas et al. discloses that such compositions can also neutralize opioids in dosage forms such as tablets or capsules. Zakharova et al. discloses that quaternary ammonium salts can solubilize drugs that one of ordinary skill in the art would reasonably expect to increase the rate of the neutralization reaction. The amount of the active and solubilizing ingredients would be routinely optimized by one of ordinary skill in the art and overlapping ranges are prima facie obviousness (see MPEP 2144.05). Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient to add in order to best achieve the desired results of drug decontamination and solubilization.
This is a provisional nonstatutory double patenting rejection.
Claims 1 – 10 and 14 – 18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 9, 13, 14, 17 – 19, 21, 22, 24 – 26 and 33 of copending Application No. 18/364,116 in view of Bell et al. (US 11,090,520), Stas et al. (US 2020/0108286), and Zakharova et al. (Organic Materials as Smart Nanocarriers for Drug Delivery, 2018). The claims of US’116 recite antimicrobial formulations comprising about 0.05 to about 25 wt% chlorite salt (500 ppm to 25,000 ppm), about 0.05 to about 25 wt% percarbonate salt and about 0.5 to about 50% surfactant (claim 1).
The presence of a quaternary ammonium salt and use of the antimicrobial formulation to neutralize opioids is not claimed.
Bell et al., Stas et al. and Zakharova et al. are discussed above.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate a quaternary ammonium surfactant into the composition of US’116 and to then use the resulting composition to neutralize opioids that are present on a surface or in a dosage form. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because Bell et al. discloses that chlorine dioxide containing solutions such as those made with the precursor chlorite can decontaminate/neutralize opioids on surfaces and Stas et al. discloses that such compositions can also neutralize opioids in dosage forms such as tablets or capsules. Zakharova et al. discloses that quaternary ammonium salts can solubilize drugs that one of ordinary skill in the art would reasonably expect to increase the rate of the neutralization reaction. The amount of the active and solubilizing ingredients would be routinely optimized by one of ordinary skill in the art and overlapping ranges are prima facie obviousness (see MPEP 2144.05). Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient to add in order to best achieve the desired results of drug decontamination and solubilization.
This is a provisional nonstatutory double patenting rejection.
Claims 1 - 10 and 14 – 18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8, 10, 13 – 17, 21 – 23 and 25 - 30 of copending Application No. 18/624,853 in view of Bell et al. (US 11,090,520), Stas et al. (US 2020/0108286), Zakharova et al. (Organic Materials as Smart Nanocarriers for Drug Delivery, 2018) and Politopoulos et al. (US 2021/0000107). The claims of US’853 recite an antimicrobial composition comprising about 1,000 to about 10,000 ppm chlorite salt, at least one quaternary ammonium salt and a buffer selected from the Markush group of claim 1. Methods of disinfecting objects with such a composition are also claimed (claims 25 – 30).
Bell et al., Stas et al. and Zakharova et al. are discussed above.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate a quaternary ammonium surfactant into the composition of US’853 and to then use the resulting composition to neutralize opioids that are present on a surface or in a dosage form. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because Bell et al. discloses that chlorine dioxide containing solutions such as those made with the precursor chlorite can decontaminate/neutralize opioids on surfaces and Stas et al. discloses that such compositions can also neutralize opioids in dosage forms such as tablets or capsules. Zakharova et al. discloses that quaternary ammonium salts can solubilize drugs that one of ordinary skill in the art would reasonably expect to increase the rate of the neutralization reaction. The amount of the active and solubilizing ingredients would be routinely optimized by one of ordinary skill in the art and overlapping ranges are prima facie obviousness (see MPEP 2144.05) based on the compositions as disclosed by Politopoulos et al. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient to add in order to best achieve the desired results of drug decontamination and solubilization.
This is a provisional nonstatutory double patenting rejection.
Claims 1- 10 and 14 – 18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 - 19 of copending Application No. 19/455,450 in view of Bell et al. (US 11,090,520) in view of Stas et al. (US 2020/0108286), and Zakharova et al. (Organic Materials as Smart Nanocarriers for Drug Delivery, 2018). The claims of US’450 recite an antimicrobial composition comprising about 2,000 to about 8,000 ppm chlorite salt, about 5,000 to about 10,000 ppm of at least one quaternary ammonium compound and about 8,000 to about 15,000 ppm sodium tetraborate (claim 1).
Bell et al., Stas et al. and Zakharova et al. are discussed above.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate a quaternary ammonium surfactant into the composition of US’450 and to then use the resulting composition to neutralize opioids that are present on a surface or in a dosage form. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because Bell et al. discloses that chlorine dioxide containing solutions such as those made with the precursor chlorite can decontaminate/neutralize opioids on surfaces and Stas et al. discloses that such compositions can also neutralize opioids in dosage forms such as tablets or capsules. Zakharova et al. discloses that quaternary ammonium salts can solubilize drugs that one of ordinary skill in the art would reasonably expect to increase the rate of the neutralization reaction. The amount of the active and solubilizing ingredients would be routinely optimized by one of ordinary skill in the art and overlapping ranges are prima facie obviousness (see MPEP 2144.05). Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient to add in order to best achieve the desired results of drug decontamination and solubilization.
This is a provisional nonstatutory double patenting rejection.
Claims 1 – 10 and 14 – 18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 - 20 of copending Application No. 19/561,807 in view of Bell et al. (US 11,090,520) in view of Stas et al. (US 2020/0108286), and Zakharova et al. (Organic Materials as Smart Nanocarriers for Drug Delivery, 2018). The claims of US’807 recite antimicrobial formulations comprising about 0.05 to about 25 wt% chlorite salt (500 ppm to 25,000 ppm), about 0.05 to about 25 wt% percarbonate salt and about 0.5 to about 50% surfactant (claim 1).
Bell et al., Stas et al. and Zakharova et al. are discussed above.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate a quaternary ammonium surfactant into the composition of US’807 and to then use the resulting composition to neutralize opioids that are present on a surface or in a dosage form. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because Bell et al. discloses that chlorine dioxide containing solutions such as those made with the precursor chlorite can decontaminate/neutralize opioids on surfaces and Stas et al. discloses that such compositions can also neutralize opioids in dosage forms such as tablets or capsules. Zakharova et al. discloses that quaternary ammonium salts can solubilize drugs that one of ordinary skill in the art would reasonably expect to increase the rate of the neutralization reaction. The amount of the active and solubilizing ingredients would be routinely optimized by one of ordinary skill in the art and overlapping ranges are prima facie obviousness (see MPEP 2144.05). Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient to add in order to best achieve the desired results of drug decontamination and solubilization.
This is a provisional nonstatutory double patenting rejection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nissa M Westerberg whose telephone number is (571)270-3532. The examiner can normally be reached M - F 8 am - 4 pm.
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/Nissa M Westerberg/Primary Examiner, Art Unit 1618