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 .
Claims 1-18 are pending in the Claim Set filed 8/11/2025.
Claims 19 and 20 have been canceled.
Herein, claims 1-18 are for examination.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on 4/26/2024 and 4/26/2024 have been considered by the examiner and an initialed copy of the IDS is included with the mailing of this office action.
Withdrawn Rejections
The rejection of the Abstract is withdrawn in view of the amendments to the abstract filed 8/11/2025.
The rejection of claims 1-20 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7, 9-17 and 22 of copending Application No. 17322842 in view of Almas (US 20170266227, cited in IDS filed 4/26/2024) [Almas (‘227)] is withdrawn in view of the claim amendments in favor of the new grounds of rejection as set for the below.
The rejection of claims 1-20 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18449222 in view of Almas (US 20170266227, cited in IDS filed 4/26/2024) [Almas (‘227)] is withdrawn in view of the claim amendments in favor of the new grounds of rejection as set for the below.
The rejection of claims 1-20 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-15, 21 and 22 of copending Application No. 17369620 [herein ‘620] in view of Almas (US 20170266227, cited in IDS filed 4/26/2024) [Almas (‘227)] is withdrawn in view of the claim amendments in favor of the new grounds of rejection as set for the below.
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 of this title, 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
The rejection of claims 1-6, 8 and 16 under 35 U.S.C. 103 as being unpatentable over Almas (US 20170266227, cited in IDS filed 4/26/2024) [Almas (‘227)] is maintained and made again. Rejection is reformulated in view of the claim amendments because claims 19 and 20 are not recited in the instant claim set filed 8/11/2025.
Regarding claims 1-6,
Almas (‘227) teaches disinfecting compositions comprising hypochlorous acid and any compound that produces hypochlorite anion (OCl-) in water, in particular, NaOCl (sodium hypochlorite, which is alkali metal salt of hypochlorous acid) and Ca(ClO2)2 (calcium chlorite), which is alkaline metal salt of chlorous acid, that is especially useful for treating biofilms in or on tissue, wherein microorganisms associated with biofilms include Candida albicans, coagulase-negative staphylococci, Enterococcus, Klebsiella pneumoniae, Pseudomonas aeruginosa, Staphylococcus aureus, and others, wherein treatment includes killing of microbes inhabiting the biofilm or removing a biofilm, inhibiting biofilm formation, and disrupting an existing biofilm (Abstract; [0006]; [0049]; [0087-0088]; [0090]; See entire document).
Particularly, Almas (‘227) teaches acetic acid at (Title; Abstract; [0003]; [0006]; [0007]; [0009]; [0012-0018]; [0033]; [0036-0038]; [0042-004]; [0045-0047]; [0049]; [0090]; [0118]; [0120]; Claims 1-6); See entire document).
Almas (‘227) teaches the hypochlorous acid component is effective against surface-level biofilms or biofilm just below the surface of a wound, while the acetic acid is able to penetrate deeper into a wound or other tissue [0007].
Regarding the compound acetic acid: a compound cannot be separated from its properties, regardless of what it types of excipients it is classified as. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present, for example, an activator.
Accordingly, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art that the teachings of Almas (‘227) makes obvious an antimicrobial formulation comprising NaOCl (Mn+[Cl(O)x]nn- (M is Sodium (Na); n = 1); x = 1), i.e., alkali metal salt of hypochlorous acid (reads on claims 1 and 2); Ca(ClO2)2 (Mn+[Cl(O)x]nn- (M is Calcium (Ca); n = 2); x = 2), i.e., alkaline metal salt of chlorous acid (reads on claims 1 and 4); acetic acid (CH3CO2H): R1XOn(R2)m where R1 = hydrogenated carbon atom (C1); X = carbon; O is oxygen and n = 2; R2 = H) (i.e., acetic acid reads an activator as recited in claims 1, 3, 5 and 6 on activator) and water (reads on a carrier).
Regarding claim 8,
Almas (‘227) teaches the compositions have a pH of from about 4.5 to about 9 [0048], of which overlaps with the claimed pH range. Where the claimed ranges overlap with the disclosures of prior art, the claim is obvious. In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003).
Regarding claim 16,
Almas (‘227) teaches the composition are formulated as a liquid, powder, lotion, cream, gel, oil, ointment, gel, solid, semi-solid formulation, or aerosol spray, wherein such formulations can be produced in a conventional manner using appropriate carriers which are well known to a person skilled in the art ([0091]; See entire document).
In addition, Almas (‘227) teaches that the compositions are particularly beneficial due to the balance between the hypochlorous acid and acetic acid, which gives the compositions the dual effect of surface, just beneath surface and deeper sub-surface treatment of biofilm infected tissue. In addition, hypochlorous acid is able to act rapidly at or near the surface; whereas acetic acid takes longer time to act and therefore can act below the wound surface [0007].
The prior art discloses the individual elements of applicant's claimed composition including the claimed alkali metal salt of hypochlorous acid (reads on claims 1 and 2); Ca(ClO2)2 (Mn+[Cl(O)x]nn- (M is Calcium (Ca); n = 2); x = 2), i.e., alkaline metal salt of chlorous acid; activator: acetic acid; carrier: water; and overlapping pH ranges, but does not appear to disclose their combination with sufficient specificity. Nevertheless, it would have been obvious to combine these individually known ingredients as Almas (‘227) their inclusion together in an antimicrobial formulation. Since this modification of the prior art represents nothing more than “the predictable use of prior art elements according to their established functions” a prima facie case of obviousness exists. All the claimed elements herein are known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
Thus, it would have been obvious for one of ordinary skill in the art to provide instantly claimed invention and one of ordinary skill would have had a reasonable expectation of success in producing the claimed invention. Therefore, in the absence of evidence to the contrary, the invention as a whole would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by Almas (‘227).
Response to Arguments
Applicants argue that Almas '227 reports disinfecting compositions containing hypochlorous acid and acetic acid for treating biofilms in or on tissue. Almas '227 discloses using compounds that generate a hypochlorite ion such as NaOCl and Ca(OC1)2. However, Almas '227 does not disclose a solid oxidized chlorine salt. Instead, Almas '227 teaches liquid states. For example, Almas '227 presents the reaction for producing hypochlorous acid compositions using aqueous NaOCl. More generally, Almas '227 states that "the compound that generates the hypochlorite anion" is an aqueous solution. Almas '227 additionally uses mL when describing amounts of the compound that generates the hypochlorite ion. Thus, Almas '227 does not teach or suggest the use of a solid oxidized chlorine salt.
Applicant’s arguments have been fully considered but they are not persuasive, because instant claims 1-6, 8 and 16 do not require that the antimicrobial formulation is free of water. In fact, claim 1 recites ‘a pharmaceutically carrier, which would include water. Further, instant claims 1-6, 8 and 16 do not require that the components of the antimicrobial compositions to be separated, i.e., stored in separate components such as multi-component container. Thus, the scope of the antimicrobial formulation does not require Ca(ClO2)2, acetic acid and water to be separated from each other. Furthermore, instant claim 1 recites the transitional phrase ‘comprising’ of which is open-ended and does not exclude additional, unrecited elements or method steps. See, e.g. Mars Inc. v. H.J. Heinz Co., 377 F.3d 1369, 1376, 71 USPQ2d 1837, 1843 (Fed. Cir. 2004), of which means the claimed invention includes the specified components but is not limited to those components and it would also include combinations of the listed components. Moreover, it is well established that Ca(ClO2)2 is a solid material as evidenced by Specification at page 5, last paragraph; at page 11: the API-P is the solid Ca(OCl)2. In addition, Agency for Toxic Substance and Disease Registry (ATSDR) Calcium Hypochlorite (CaCl2O2)/Sodium Hypochlorite (NaOCI), (cited in the IDS filed 4/26/2024, Cite No.39) (ATSDR) discloses that calcium hypochlorite (Ca(OCl)2) is a white powder (Description: page 1), thereby Ca(OCl)2 used in ‘Almas 227 is an oxidized chlorine salt, of which is identical an oxidized chlorine salt, as instantly claimed. Furthermore, ATSDR is sufficient evidence that Ca(OCl)2 as taught by Almas ‘227 exists in powder form. A chemical composition and its properties are inseparable. Further, the examiner would like to point out the instant 8 recites a pH between about 4 and about 8, where it well established that pH is determined in water (it the measure of hydrogen ion concentration in an aqueous solution). Therefore, the antimicrobial formulation as instantly claimed would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention in view of teachings of the prior art of Almas ‘227, as discussed above.
Response to arguments is provided at the end of the rejections, as follows:
The rejection of claim 7 under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Almas (‘227) as applied to claims 1-6, 8 and 16 above and further in view of Panicheva et al (US 20160143944, cited in IDS filed 4/26/2024, Cite No. 6) [Panicheva] and Wiggins (USP 6,060,233) [Wiggins] is maintained and made again. Rejection is reformulated in view of the claim amendments because claims 19 and 20 are not recited in the instant claim set filed 8/11/2025.
The teachings of Almas (‘227) are described above.
Almas (‘227) differs from the claims in that the document does not teach that the formulation of claim 1 has an osmolality in the range of about 0.1 mOsm to about 500 mOsm.
However, Panicheva and Wiggins, as a whole, cure the deficiency.
Regarding claim 7,
As Almas (‘227) teaches the carrier is an aqueous solution of saline (i.e., NaCl solution) such that the composition is isotonic with respect to blood [0124].
Panicheva teaches a disinfectant composition comprising sodium hypochlorous acid, and saline (sodium chloride and water). Panicheva teaches that the disinfectant composition can be made isotonic with respective to physiological fluids by the addition of sodium chloride (NaCl) at varying concentrations (Abstract; [0005-0016]).
Wiggins teaches cells in an isotonic solution neither shrink nor swell substantially, wherein an osmolality between about 280-320 for solutions is preferably for preservation mammalian biological materials (col.5, lns.28-40; See entire document).
Thus, one skilled in the art would have recognized the benefit of providing an antimicrobial formulation having an osmolality in the range of about 280-320, e.g., cells in an isotonic solution neither shrink nor swell substantially, in accordance with the guidance provided by the teachings of Wiggins.
Accordingly, it would have been well within the purview of one of ordinary skill in art to optimize an amount of saline (sodium chloride (NaCl) solution) to provide an antimicrobial composition that is an isotonic solution, wherein one skilled in the art would have been motivated to optimize a solution to provide an osmolality in the range of about 280-320 mOsm to provide an antimicrobial and/or inhalation formulation that does not substantially shrink or swell mammalian cells having a reasonable expectation of success. Optimization of parameters is a routine practice that would be obvious to a person of ordinary skill in the art to employ and reasonably expect success; See In re Aller, 220 F.2d 454, 456, 105 USPQ 233,235 (CCPA 1955). As MPEP 2144.05 recites ‘where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine optimization. Moreover, it would have been customary for an artisan of ordinary skill to determine the optimal osmolality to best achieve the desired results. Also, Furthermore, a formulation having an osmolality in the range of about 280-320 mOsm lies within the claimed range of 0.1 mOsm to about 500 mOsm. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257,191 USPQ 90 (CCPA 1976); In re Woodruff, 91 9 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). MPEP 2144.05. Moreover, there is no unobvious distinction between the structural and functional characteristics of the claimed antimicrobial formulation and the prior art composition as taught by Almas (‘227), Panicheva and Wiggins, as a whole. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977).
The rejection of claim 9-12 under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Almas (‘227) as applied to claims 1-6, 8 and 16 above and further in view of Almas (US 20160271171, cited in IDS filed 4/26/2024), [Almas (‘171)] is maintained and made again. Rejection is reformulated in view of the claim amendments because claims 19 and 20 are not recited in the instant claim set filed 8/11/2025.
The teachings of Almas (‘227) are described above, wherein the compositions can be combined with excipients, carriers, emulsifiers, polymers, or other ingredients, examples of which are discussed in U.S. Patent Application 2016/0271171.
Almas (‘227) differs from the claims in that the document does not teach that the further comprising a viscosity-enhancing agent.
However, Almas (‘171) cures the deficiencies.
Regarding claims 9-12,
Almas (‘171) teaches the disinfectant composition further contains acrylate copolymers including polyacrylic acid polymers ([0013], [0052], [0062]; claims 9 and 24), thereby meeting the claims ‘viscosity-enhancing agent’ of claims 9-12. Notable, polyacrylic acid is recited in claim 12. Furthermore, a compound cannot be separated from its properties, regardless of what type of compound it is classified as, e.g., viscosity-enhancing agent is resistant to oxidation by the oxidized chlorine salt. Applicant's attention is directed to MPEP 2112.01 II, which discloses ‘Products of identical chemical composition cannot have mutually exclusive properties.’ In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). In this case, ‘polyacrylic acid’ will retain its properties as a viscosity-enhancing agent that would necessarily be resistant to oxidation by the oxidized chlorine salt, wherein the viscosity-enhancing agent comprises a water-soluble gelling agent such that the skilled artisan would expect that its functionality would remain consistent.
All the claimed elements herein are known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
Thus, it would have been obvious for one of ordinary skill in the art to provide instantly claimed invention and one of ordinary skill would have had a reasonable expectation of success in producing the claimed invention. Therefore, in the absence of evidence to the contrary, the invention as a whole would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by Almas (‘227) and Almas (‘171), as a whole.
The rejection of claims 13-15 under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Almas (‘227) as applied to claims 1-6, 8 and 16 above and further in view of Kang et al (US 20180010080, cited in IDS filed 4/26/2024, Cite No. 6) [Kang] is maintained and made again. Rejection is reformulated in view of the claim amendments because claims 19 and 20 are not recited in the instant claim set filed 8/11/2025.
The teachings of Almas (‘227) are described above.
Almas (‘227) differs from the claims in that the document does not teach that the formulation further comprises a colorimetric dye.
However, Kang cures the deficiencies.
Regarding claims 13-15,
Kang teaches an aqueous disinfectant comprising sodium hypochlorous, acetic acid, and water, wherein the disinfectant further contains a water-soluble pigment (dye) such a methylene blue (a reduction-oxidation dye), which provides a visual indicator of the presence of an oxidized chloride compound, as well as, color stability to the aqueous disinfectant (Abstract; [00014]-[0020], [0024], [0032]-[0035], [0040]-[0053], [0087], [0152], [0196], [0200], [0202], [0204]; claims 1-15 and 23).
It would have been obvious to one of ordinary skill in the art to include a dye such as methylene blue in the disinfectant composition of Almas ‘059, and produce the claimed invention. One of ordinary skill in the art would have been motivated to do so because as discussed above, Kang provided the guidance to do so by teaching that a dye such as methylene blue can be added to the disinfectant composition containing sodium hypochlorite, acetic acid, and water of Almas ‘059 so as to the dye can function as a visual indicator for the presence of an oxidized chlorine compound (sodium hypochlorite), as well as, color stability to the disinfectant. Thus, an ordinary artisan seeking to produce a disinfectant composition that has visual indication of the presence of sodium hypochlorite, as well as, color stability, would have looked to including a dye such as methylene blue to the disinfectant composition of Almas ‘059, and achieve Applicant’s claimed invention with reasonable expectation of success.
Thus, it would have been obvious for one of ordinary skill in the art to provide instantly claimed invention and one of ordinary skill would have had a reasonable expectation of success in producing the claimed invention. Therefore, in the absence of evidence to the contrary, the invention as a whole would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by Almas (‘227) and Almas (‘171), as a whole.
The rejection of claims 17 and 18 under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Almas (‘227) applied to claims 1-6, 8, 16, 19 and 20 above and further in view of Almas (US 20180179059, cited in IDS filed 4/26/2024) Alma (‘059) is maintained and made again. Rejection is reformulated in view of the claim amendments because claims 19 and 20 are not recited in the instant claim set filed 8/11/2025.
The teachings of Almas (‘227) are described above.
Almas (‘227) differs from the claims in that the document does not teach that the formulation is produced and stored in a multi-compartment container.
However, Almas (‘059) cures the deficiency.
Regarding claims 17 and 18,
Almas (‘059) teaches a multi-chamber hypochlorous dispenser, wherein the present invention provides a multi-chambered container for preparation, dispensing, and long term, stable storage of hypochlorous acid (Title: Abstract; [0006]; Figs.1-4; See entire document).
Almas (‘059) teaches that hypochlorous acid (HOC!) is a weak acid that is known to rapidly inactivate bacteria, algae, fungus, and other organics, making it an effective agent across a broad range of microorganisms, wherein due to the combination of its biocide properties and its safety profile, hypochlorous acid has been found to have many beneficial uses across many different industries, such as the medical, foodservice, food retail, agricultural, wound care, laboratory, hospitality, dental, or floral industries [0004].
Furthermore, Almas (‘059) teaches in order to prolong stability, systems of the invention provide multi-chambered containers that can keep separate the components that are used to produce HOCl compositions of the invention and allow for on-site and on-demand preparation. Additionally, once mixed, the present invention stabilizes the HOCl solution by regulating pH, removing metal ions and chloride ions, and reducing ionic strength [0018].
Almas (‘059) teaches that any compound that produces a hypochlorite anion (OCl-) in water may be used with methods of the invention. Exemplary compounds include NaOCl and Ca(OCl)2. Further, any compound that produces a proton (H+) in water may be used with methods of the invention such as acetic acid, wherein acetic acid is a weaker acid than HCI with a preferred pKa since it is more able to maintain the preferred pH level [0019-0021].
Almas (‘059) teaches a system for storing and producing hypochlorous acid (HOCl), the system comprising a container comprising a first compartment, a second compartment, and a third compartment, wherein the first compartment contains a compound that generates a hypochlorite anion (OCI-) in the presence of water, e.g., NaOCl, Mag(OCl)2 or Ca(OCl)2, and the second compartment contains a compound that generates a proton (H+), e.g., acetic acid, in the presence of water; a first one-way valve that permits fluid flow from the first compartment to the third compartment; and a second one-way valve that permits fluid flow from the second compartment to the third compartment, wherein the system is configured to produce hypochlorous acid (HOC]) having a pH from about 4.5 to about 7 .5 in the third compartment after introduction into the third compartment of the compound that generates a hypochlorite anion and the compound that generates a proton from the first and second compartments respectively (Almas (‘059): claims 1-22; see entire document).
Thus, it would have been obvious for one of ordinary skill in the art to provide hypochlorous acid (HOCl), wherein hypochlorous acid is produced and stored in a multi-compartment container, wherein fluid and solid components are contained within separate respective compartments prior to combination of said fluid and solid components to produce a composition (makes obvious instant claims 17 and 18). Those skilled in the art would have been motivated to do so because in order to prolong stability, such that multi-chambered containers keep separate the components that are used to produce HOCl and allow for on-site and on-demand preparation, wherein once mixed, of which stabilizes the HOCl solution by regulating pH, removing metal ions and chloride ions, and reducing ionic strength in accordance with the teachings of Almas (‘059).
All the claimed elements herein are known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
Thus, it would have been obvious for one of ordinary skill in the art to provide instantly claimed invention and one of ordinary skill would have had a reasonable expectation of success in producing the claimed invention. Therefore, in the absence of evidence to the contrary, the invention as a whole would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by Almas (‘227).
Response to Arguments
Applicants argue none of the cited references: Panicheva, Wiggins Kang and Almas ‘059, make mention of a solid oxidized chlorine salt.
Applicant’s arguments have been fully considered but they are not persuasive, because the antimicrobial formulation as instantly claimed would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention in view of teachings of the prior art of Almas ‘227, as discussed above. Notably, it is well established that Ca(ClO2)2 is a solid material as evidenced by Specification at page 5, last paragraph; at page 11: the API-P is the solid Ca(OCl)2. In addition, Agency for Toxic Substance and Disease Registry (ATSDR) Calcium Hypochlorite (CaCl2O2)/Sodium Hypochlorite (NaOCI), (cited in the IDS filed 4/26/2024, Cite No.39) (ATSDR) discloses that calcium hypochlorite (Ca(OCl)2) is a white powder (Description: page 1), thereby Ca(OCl)2 used in ‘Almas 227 is an oxidized chlorine salt, of which is identical an oxidized chlorine salt, as instantly claimed (also, See the teachings of Almas ‘227 and Response to Arguments directed to the teachings of Alma ‘227, all of which is fully incorporated herein)
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 1-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7, 9-17 and 22 of copending Application No. 17322842 (herein’ 842). Rejection is reformulated in view of the claim amendments because claims 19 and 20 are not recited in the instant claim set filed 8/11/2025.
Although the claims at issue are not identical, they are not patentably distinct from each other because Instant Claims and ‘842 claims are directed to common subject matter.
Instant claims and the subject matter of the ‘842 claims significantly overlaps with the subject of the instant claims, i.e., a composition comprising an oxidized chlorine salt such as an alkali metal or alkaline earth metal salt of hypochlorous acid or chlorous acid, an activator such as acetic acid, a pharmaceutically-acceptable diluent, adjuvant, or carrier, a viscosity-enhancing agent, and a reduction-oxidation dye, wherein the composition is produced and stored in a multi-compartment container, wherein the composition has a pH between about 4 and about 8, and has an osmolality in the isotonic range.
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the antimicrobial formulation in view of the subject matter as recited in the ‘842 claims. Particularly, there is no unobvious distinction between the structural and functional characteristics of the claimed antimicrobial formulation and the disinfectant composition of the ‘842 claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of copending Application No. 18449222 (herein’ 222). Rejection is reformulated in view of the claim amendments because claims 19 and 20 are not recited in the instant claim set filed 8/11/2025.
Although the claims at issue are not identical, they are not patentably distinct from each other because Instant Claims and ‘922 claims are directed to common subject matter.
Instant claims and the subject matter of the ‘222 claims significantly overlaps with the subject of the instant claims, i.e., a composition comprising an oxidized chlorine salt such as an alkali metal or alkaline earth metal salt of hypochlorous acid or chlorous acid, an activator such as acetic acid, a pharmaceutically-acceptable diluent, adjuvant, or carrier, a viscosity-enhancing agent, and a reduction-oxidation dye, wherein the composition is produced and stored in a multi-compartment container, wherein the composition has a pH between about 4 and about 8, and has an osmolality in the isotonic range and provided as an inhalation formulation.
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the antimicrobial formulation in view of the subject matter as recited in the ‘222 claims. Particularly, there is no unobvious distinction between the structural and functional characteristics of the claimed antimicrobial formulation and the disinfectant composition of the ‘842 claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-15, 21 and 22 of copending Application No. 17369620 [herein ‘620] in view of Almas (US 20170266227, cited in IDS filed 4/26/2024) [Almas (‘227)].
Although the claims at issue are not identical, they are not patentably distinct from each other because Instant Claims and ‘620 claims are directed to common subject matter.
Instant claims and the subject matter of the ‘620 claims significantly overlaps with the subject of the instant claims, particularly, a solid oxidized chlorine salt such as an alkali metal or alkaline earth metal salt of hypochlorous acid or chlorous acid, an activator such as acetic acid (recited in claims 21 and 22), a pharmaceutically-acceptable diluent, adjuvant, or carrier, a viscosity-enhancing agent, and a reduction-oxidation dye, wherein the composition is produced and stored in a multi-compartment container, wherein the composition has a pH between about 4 and about 8, and has an osmolality in the isotonic range.
Although, the solid oxidized chlorine salt of the ‘620 claims is provided in a device, nonetheless, it is prima facie obvious to provide the formulation as recited in instant claims in view of the subject matter of the ‘620 claims, wherein there is no unobvious distinction between the structural and functional characteristics of the claimed antimicrobial formulation and the prior art composition. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the antimicrobial formulation in view of the subject matter as recited in the ‘620 claims. Particularly, there is no unobvious distinction between the structural and functional characteristics of the claimed antimicrobial formulation and the disinfectant composition of the ‘620 claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant argue that the double patenting rejections be held in abeyance until the claims are otherwise in condition for allowance.
Applicant's arguments have been fully considered but they are not persuasive, because Applicants did not distinctly and specifically point out the supposed errors in the Double Patenting rejection. Therefore, the Double Patenting rejection(s) of record have been maintained as no action regarding these rejections has been taken by Applicants at this time. Further, a request to hold a rejection in abeyance is not a proper response to a Double Patenting rejection (MPEP 37 CFR 1.111 (b) and 714.02).
Conclusions
No claim is 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.
Contact Information
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/T.W./ Examiner, Art Unit 1619
/SARAH ALAWADI/ Primary Examiner, Art Unit 1619