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 .
Priority
The applicant claims benefit to US Provisional application No 63/103881 and designates the instant application as a continuation in part of PCT/US20/55772. Neither of these prior filed applications provide adequate support in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for the claims. All of the current claims recite a microemulsion as a product, directly, or indirectly, or as a product that is employed in a claimed method, but neither of the two prior filed applications make any mention of microemulsions. Therefore the effectively filed date for the instant claims is January 14, 2022.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 3, 8-18 and 20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites a composition that “forms a physical barrier on the mucosal passage when applied, thereby preventing the virus from attaching to the mucosal tissue”. It is unclear what is required of the composition to meet the “preventing the virus from attaching” functionality. The recitation is conditional, but the circumstances are not defined. Thus it is not clear how long viral attachment has to be prevented. It is also unclear if a certain applied amount is required for a composition to be capable of performing the function. This raises the issue of if an applied amount of a composition with recited components does not prevent viral attachment whether that composition is in the instant claim scope. It also is not clear if the recitation implicitly requires the presence of particular unrecited components. Further, claim 12 recites a method of inhibiting respiratory infection and depends from claim 1; however, the conditional recitation in claim 1 makes it unclear whether the practice of the method claim requires preventing the virus from attaching to the mucosal tissue.
For the sake of compact prosecution and the application of prior art, compositions that have the recited configuration (microemulsion), components and proportions will be deemed sufficient to fulfill the functional limitations of claim 1. Clarification is still required.
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.
Claims 1, 3, 8-17, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Rocabayera Bonvilla et al. (previously cited) in view of Wollmer et al. (previously cited) and Powell et al. (previously cited).
Rocabayera Bonvilla et al. teach antiviral compositions comprising lauroyl-L-arginine ethyl ester (LAE) (also known as ethyl lauryl arginine hydrochloride) as the cationic surfactant antiviral active (see abstract and page 1 lines 9-14, and formula 1; instant claims 1 and 5). In addition to its known antibacterial activity, they also teach of its effectiveness against multiple varieties of virus such as a bovine parainfluenza, herpes simplex type 1, and vaccinia (see page 7 lines 15-28 and examples 1-3). Rocabayera Bonvilla et al. go on to teach the antiviral concentration of the LAE to range from 2 to 20,000 ppm (0.0002 to 2 wt%) (see page 8 lines 25-30; instant claim 2). Surface application concentrations are detailed as 0.01 to 100 mg/dm2 ( see page 9 lines 17-22; instant claims 10 and 15). They additionally teach the formulation prepared for application to inanimate objects as well as transnasal application in forms such as emulsions, sprays, and nose drops (see page 9 lines 4-7 and page 10 lines 5-15). Protective application to a human or animal is also envisioned (see claim 7). A microemulsion is not explicitly detailed.
Wollmer et al. detail a microemulsion for inhibiting or reducing the severity of airway diseases via airborne particles that include viruses (see abstract and paragraph 24). Varieties of influenza are envisioned as being addressed (see example 10). They further detail including pharmaceutical agents in the composition that include antiviral and antibacterial compounds (see paragraphs 27 and 66). The microemulsion dispersed phase is sized at 10 to 150 nm and includes propylene glycol and 18 wt% polyethylene glycol (meeting limitations of glycol) in an exemplary embodiment (see paragraph 34 and example 1; instant claims 1, 3, and 11). The preparation pH exceeds 5.5 (see paragraph 52; instant claim 8). Wollmer et al. go on to teach application to the membrane surfaces of the nose and pharynx (nasopharynx) of a mammal or human via spray or drops (see paragraphs 27-29 and 61-62; instant claims 9-14, 17, and 20). Pretreatment of a target is detailed (see paragraph example 10; instant claim 16). In addition, the composition may also be applied to air filters, but regardless of the application locale, the composition is envisioned to capture airborne particles (see paragraph 61).
Powell et al. teach a composition envisioned for application to the interior nasal surfaces that includes an anti-infective metal active to treat or protect against respiratory infection (see abstract and page 27 lines 34-36). Viral infections are envisioned targets for treatment and infection deterrence (see claim 12). The compounds preferably include a copper ion and several particular copper salts are envisioned such as copper acetate and copper gluconate (see page 13 lines 21-27 and page 14 lines 1 and 27-31). These salts are present at 5 mmolal to 3.5 molal and are more narrowly claimed at 20 to 500 mmolal (see page 14 lines 15-25 and claim 28).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to formulate the LAE (ELAH) containing composition of Rocabayera Bonvilla et al. as a microemulsion employing the composition of Wollmer et al. as the delivery vehicle. This modification would have been obvious because Rocabayera Bonvilla et al. teach their composition as an emulsion and as an anti-infective composition that is applied transnasally (intranasally), while Wollmer et al. teach a particular known variety of emulsion that is explicitly envisioned for intranasal application for inhibition of infection and envisioned the inclusion of antiviral compounds. This modification would have been obvious as the simple substitution of one known element for another in order to yield a predictable outcome (e.g., specific intranasal microemulsion for generic emulsion). The pH for the composition taught by Wollmer et al. would follow and overlaps with that instantly claimed, thereby rendering the claimed range obvious. “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, 919 F.2d 1575, 16 USPQ2d 1934 (Fed.Cir. 1990)” (see MPEP 2144.05). It additionally would have been obvious to add a copper salt, and specifically copper gluconate, to the microemulsion composition as an additional anti-infective/anti-viral active as taught by Powell et al. “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (see MPEP 2144.06). The application of the taught or claimed concentration of the metal salt as detailed by Powell et al. would follow and results in a range whose minimum is about 0.2 wt% or more narrowly at about 0.9 to about 22.5 wt% copper gluconate (as calculated by the examiner). These ranges along with that for the LAE/ELAH overlap with those instantly claimed, thereby rendering the claimed ranges obvious (see instant claim 1). According to MPEP 2145II, mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979). In addition, the fact that an inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). Thus the instantly claimed functional properties concerning the LAE, copper gluconate, and plasticizer and solvent containing microemulsion follows from the fact that the composition rendered obvious by the modification to the composition of Rocabayera Bonvilla et al. has the claimed components in the claimed configuration at the claimed proportions. Application of the modified composition to the nose and/or pharynx (nasopharynx) locales that Wollmer et al. teach would follow as would prophylactic application and the amount to apply detailed by Rocabayera Bonvilla et al. The instant claims recite the active step of “applying…to the nasal cavity of a subject at risk of SARS-CoV-2 viral infection” and this population is the same as that envisioned by Rocabayera Bonvilla et al. The “inhibiting…infection…in a subject” in the preamble and/or body of instant claim 12 embraces subjects before or after infection. The limitation “forming a physical barrier on the mucosal tissue” is met by the combination of claimed plasticizer and other components in the microemulsion vehicle of Wollmer et al. Further, the application of the modified composition to any nose and/or pharynx containing animal meets the limitations for the instant patient population. A particular length of residence time is not linked to “prolonged”, thus the duration over which the modified composition retains the LAE in the nasal cavity meets the limitation of “prolonged” (see instant claim 17). Therefore claims 1, 3, 8-17, and 20 are obvious over Rocabayera Bonvilla et al. in view of Wollmer et al., and Powell et al.
Claims 1, 3, 8-17, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Rocabayera Bonvilla et al. in view of Wollmer et al., and Powell et al. as applied to claims 1, 3, 8-17, and 20 above, and further in view of Shah et al. (previously cited).
Rocabayera Bonvilla et al. in view of Wollmer et al., and Powell et al. render obvious the limitations of instant claims 1, 3, 8-17, and 20, where an antiviral microemulsion is applied to the nasal cavity. A residence time is not explicitly detailed.
Shah et al. teach a microemulsion for intranasal delivery and the benefit of a prolonged retention time to allow for desired drug effect (see abstract and page 919 first column fourth paragraph). In particular, they detail that the inclusion of the cationic mucoadhesive molecule chitosan was able to retain 79% of the composition and 98% of its drug active on an inclined mucosal surface in the midst of constant, slow rinsing for an hour (see page 922 first column last partial paragraph-second column first partial paragraph and table 4). A similar microemulsion devoid of the chitosan was retained at 29% and held 99 % of its drug active under the same test conditions (see table 4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to formulate the applied microemulsion of Rocabayera Bonvilla et al. in view of Wollmer et al., and Powell et al. with chitosan as taught by Shah et al. in order to prolong its retention in the nasal cavity. Given the retention time obtained by Shah et al. such a modification would permit the artisan to attain the instantly claimed residence time. The modification is obvious as the application of the same technique to a similar product in order to yield the same improvement. Therefore claims 1, 3, 8-17, and 19-20 are obvious over Rocabayera Bonvilla et al. in view of Wollmer et al., and Powell et al., and Shah et al.
Claims 1, 3, and 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Boyd et al. (previously cited) in view of Chung et al. (previously cited).
Boyd et al. teach a mouth rinse composed of acyl arginine alkyl ester salts as antimicrobial active compounds (see abstract; instant claims 9 and 14). A preferred compound in the category is the hydrogen chloride salt of ethyl lauroyl arginine (ELAH), an arginine ester cationic surfactant (see paragraph 24; instant claims 1 and 5). They go on to teach the inclusion of flavoring oils as well as antibacterial metal salts where coppers salts such as copper gluconate are envisioned (see paragraphs 29 and 31; instant claims 1 and 6). The ELAH is exemplified at 0.1, 0.2, or 0.3 wt% in the composition while the antibacterial metal salt is taught present at 0.1 to 2 wt% (see examples I and II and paragraph 31). The presence of flavor, water, glycerin (plasticizer), and propylene glycol (plasticizer) is also exemplified, where the latter two are present at a total of 20 wt% at (see example I; instant claims 3-4). Boyd et al. further teach the composition pH to be 6 to 8 (see paragraph 20; instant claim 8). Application of their composition to the oral cavity is implicit in the name. Formulation of the composition as a microemulsion is not detailed.
Chung et al. teach a microemulsion mouthwash formulation to permit incorporation of a hydrophobic flavoring in a transparent composition that is stable with low levels of lower alcohols (see abstract and examples I-II). They also highlight such a preparation with glycerin (plasticizer) and propylene glycol (solvent) (see column 6 lines 3-17; instant claim 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare and apply the ELAH and flavor containing mouth rinse of Boyd et al. with an oil flavoring and a copper salt, namely copper gluconate because the suggest to do so. Additionally, it also would have been obvious to formulate this composition as a microemulsion in light of Chung et al. who teach of the ability of such preparations to facilitate the inclusion of an oil flavoring in a stable preparation that is desirably transparent. They also include several of the same excipients as Boyd et al. This modification would have been obvious as the application of the same technique to a similar product in order to yield the same improvement. The resulting composition has proportions of ELAH, copper salt/copper gluconate, and plasticizers that meet or overlap with those instantly claimed, thereby rendering the claimed ranges obvious (see MPEP 2144.05). A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Here the recitation of the composition as a nasal composition or as a nasal spray are intended uses. The topical composition rendered obvious by Boyd et al. in view of Chung et al. is a liquid that could be sprayed and applied to the nose; therefore it meets the required limitations of the intended use recitation. The application of the composition to the oral cavity then follows because the use of a composition for its intended use is obvious. According to MPEP 2145II, mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979). In addition, the fact that an inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). Thus the functional properties concerning the ELAH and copper salt as an antiviral combination follows from the fact that they are present in the claimed configuration and are obvious at the claimed proportions (see instant claim 1). Therefore claims 1, 3, and 8-9 are obvious over Boyd et al. in view of Chung et al.
Claims 1, 3, 8-9, 11-12, 14, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Boyd et al. in view of Chung et al. as applied to claims 1, 3, 8-9, 12, 14, and 16 above, and further in view of Mordas et al. (previously cited).
Boyd et al. in view of Chung et al. render obvious the limitations of instant claims 1, 3, 8-9, 12, 14, and 16, where a microemulsion mouthwash is the composition. The diameter in the microemulsion is not detailed.
Mordas et al. teach a microemulsion antibacterial mouth rinse (see abstract). Here they detail the diameter of the aggregated features (micelles) of the microemulsion to be less than 200 nm (see paragraph 50).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare the microemulsion of Boyd et al. in view of Chung et al. with a size of 200 nm or less as taught by Mordas et al. because they teach it is desirable/useful for antibacterial microemulsion mouth rinses to have this size. The resulting range overlaps with that instantly claimed, thereby rendering the claimed range obvious (see MPEP 2144.05). Therefore claims 1, 3, 8-9, 11-12, 14, and 16 are obvious over Boyd et al. in view of Chung et al. and Mordas et al.
Claims 1, 3, and 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Ming et al. (previously cited) in view of Leung et al. (US PGPub No. 2002/007315) and Salamone et al. (previously cited) as evidenced by the USP reference (previously cited).
Ming et al. teach an antimicrobial wound treatment composition composed of a cationic surfactant derived from the condensation of fatty acids and esterified dibasic amin acids such as lauric arginine and an antimicrobial metal (see abstract and paragraph 14; instant claim 1). A preferred cationic surfactant in this category is ethyl ester of the lauramide of arginine monohydrochloride (ELAH), an arginine ester cationic surfactant (see paragraph 12; instant claim 1). The antimicrobial metals may be provided as elemental or compound forms where salts, namely acetic acid salts (acetate), are an envisioned compound form and copper is an envisioned metal (see paragraphs 12-13; instant claim 1). The ELAH is preferably present at about 0.01 to about 1 wt% in the composition, while the antibacterial metal is preferably present at about 0.01 to about 1.5 wt% (see paragraph 16; instant claim 1). The composition may be a stand-alone liquid composition that can be applied directly to a wound or applied to a medical device surface, where Ming et al. discuss the composition applied to a 2-0 polyglactin 910 suture providing each of the ELAH and antimicrobial metal at 0.001-100 mg/cm (see paragraphs 14-16). The USP reference details that this suture size has a diameter of 0.3 to 0.339 mm which corresponds to a surface density range of ELAH and metal with a maximum of about 0.09 mg/dm2 (see table 2; as calculated by the examiner; instant claim 10). Formulation of the composition as a microemulsion is not detailed and a gluconate salt of copper is not explicitly detailed.
Leung et al. teach topical wound healing compositions that include an antimicrobial active (see abstract and paragraph 34). Preferred antimicrobial actives are envisioned to include copper gluconate which is exemplified at 0.4 wt% in the composition (see example 4 and paragraph 34; instant claim 1).
Salamone et al. teach antimicrobial wound treatment compositions that are envisioned as stand-alone preparations or applied to a medical device surface (see abstract). Various liquid forms are envisioned that include microemulsions to facilitate the incorporation of water insoluble ingredients (see paragraphs 66 and 104). Aromatic essential oils as fragrance are also taught as desirable components (see paragraph 105).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare the composition of Ming et al., where the preferred ELAH is present with copper gluconate. The choice of copper gluconate would have been obvious because it is a particular copper compound that was known for inclusion in wound treating compositions for its antimicrobial properties, as detailed by Leung et al. It additionally would have been obvious to formulate the composition as a microemulsion with an oil fragrance because this variety of liquid form was known to be suitable for wound treatment compositions that can also be applied to a medical device surface and such fragrance were desired additions. This modification is obvious as the application of same technique to a similar product in order to yield the same improvement and as the simple substitution of one known element for another in order to yield a predictable outcome (e.g., generic liquid formulation vs microemulsion liquid formulation). The 0.01 to 1.5 wt% copper ion concentration of Ming et al. corresponds to a copper gluconate concentration of 0.07 to 10.8 wt% while Leung et al exemplify its present at 0.4 wt%. The compositions rendered obvious by the modification to Ming et al. has proportions of ELAH, copper gluconate, and possible surface densities that meet or overlap with those instantly claimed, thereby rendering the claimed ranges obvious (see MPEP 2144.05; instant claims 1 and 10). A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Here the recitation of the composition as a nasal composition or as a nasal spray are intended uses. The topical composition rendered obvious by Ming et al. in view of Leung et al. and Salamone et al. is a liquid that could be sprayed and applied to the nose; therefore it meets the required limitations of the intended use recitation. According to MPEP 2145II, mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979). In addition, the fact that an inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). Thus the functional properties concerning the ELAH and copper salt as an antiviral combination follows from the fact that they are present in the claimed configuration and are obvious at the claimed proportions (see instant claim 1). Therefore claims 1, 3, and 9-10 are obvious over Ming et al. in view of Leung et al. and Salamone et al. as evidenced by the USP reference.
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, 3, and 8-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8-12, 17, and 22-23 of U.S. Patent No. 8,287,843 in view of Boyd et al and Chung et al.
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims recite an oral care composition that can be a liquid and comprises an arginine ester. More specifically both claim this compound to be the hydrochloride salt of ethyl lauroyl arginine. The compound is present at 0.02 to 2 wt% in the patented composition. The patented composition may also have a metal salt. A copper salt is not explicitly recited in the claims.
Boyd et al. teach a mouth rinse composed of acyl arginine alkyl ester salts as antimicrobial active compounds (see abstract). A preferred compound in the category is the hydrogen chloride salt of ethyl lauroyl arginine (ELAH), an arginine ester cationic surfactant (see paragraph 24). They go on to teach the inclusion of flavoring oils as well as antibacterial metal salts where coppers salts such as copper gluconate are envisioned (see paragraphs 29 and 31). The ELAH is exemplified at 0.1, 0.2, or 0.3 wt% in the composition while the antibacterial metal salt is taught present at 0.1 to 2 wt% (see examples I and II and paragraph 31). The presence of flavor, water, glycerin (plasticizer), and propylene glycol (plasticizer) is also exemplified, where the latter two are present at a total of 20 wt% at (see example I). Boyd et al. further teach the composition pH to be 6 to 8 (see paragraph 20).
Chung et al. teach a microemulsion mouthwash formulation to permit incorporation of a hydrophobic flavoring in a transparent composition that is stable with low levels of lower alcohols (see abstract and examples I-II). They also highlight such a preparation with glycerin and propylene glycol (see example 4 and column 6 lines 3-17).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare the patented composition as a liquid mouth rinse as taught by Body et al who detail such a form as known to be desirable for oral care formulation with ELAH as an active. It also would have been obvious to add an oil flavoring and a copper salt, namely copper gluconate because Boyd et al. suggest to do so for the benefits they confer. This modification would have been obvious as the application of the same technique to a similar product in order to yield the same improvement. Additionally, it also would have been obvious to formulate this composition as a microemulsion in light of Chung et al. who teach of the ability of such preparations to facilitate the inclusion of an oil flavoring in a stable preparation that is desirably transparent. They also include several of the same excipients as Boyd et al. This modification would have been obvious as the application of the same technique to a similar product in order to yield the same improvement. The resulting composition has proportions of ELAH, copper gluconate, and plasticizers that meet or overlap with those instantly claimed, thereby rendering the claimed ranges obvious (see MPEP 2144.05). A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Here the recitation of the composition as a nasal composition or as a nasal spray are intended uses. The topical composition rendered obvious by the modified patented claims is a liquid that could be sprayed and applied to the nose; therefore it meets the required limitations of the intended use recitation. According to MPEP 2145II, mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979). In addition, the fact that an inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). Thus the functional properties concerning the ELAH and copper salt as an antiviral combination follows from the fact that they are present in the claimed configuration and are obvious at the claimed proportions. Therefore claims 1, 3, and 8-9 are obvious over claims 1, 8-12, 17, and 22-23 of U.S. Patent No. 8,287,843 in view of Boyd et al. and Chung et al.
Claims 1, 3, 8-9 and 11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8-12, 17, and 22-23 of U.S. Patent No. 8,287,843 in view of Boyd et al. and Chung et al. as applied to claims 1, 3, and 8-9 above, and further in view of Mordas et al.
Claims 1, 8-12, 17, and 22-23 of U.S. Patent No. 8,287,843 in view of Boyd et al. and Chung et al. render obvious the limitations of instant claims 1, 3, and 8-9, where microemulsion mouthwash is the composition. The diameter in the microemulsion is not detailed.
Mordas et al. teach a microemulsion antibacterial mouth rinse (see abstract). Here they detail the diameter of the aggregated features (micelles) of the microemulsion to be less than 200 nm (see paragraph 50).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare the microemulsion of the modified patented claims with a size of 200 nm or less as taught by Mordas et al. because they teach it is desirable/useful for antibacterial microemulsion mouth rinses to have this size. The resulting range overlaps with that instantly claimed, thereby rendering the claimed range obvious (see MPEP 2144.05). Therefore claims 1, 3, 8-9, and 11 are obvious over claims 1, 8-12, 17, and 22-23 of U.S. Patent No. 8,287,843 in view of Boyd et al., Chung et al., and Mordas et al.
Declaration
The declaration under 37 CFR 1.130(a) filed December 1, 2025 is sufficient to overcome the rejection of claims 1, 3-6, 8-14, and 16-17 based upon Thacore et al. in view of Powell et al. and Wollmer et al. as set forth in the last Office action.
Response to Arguments
Applicant's arguments filed December 1, 2025 have been fully considered. In light of the amendment to the claims, the objection to the claims, rejection under 35 USC 112(b), and the rejection over Rocabayera Bonvilla et al. in view of Wollmer et al., Powell et al., and Sagripanti et al. are hereby withdrawn. The remaining rejections are maintained or modified in light of the amendment. The arguments directed toward Boyd in view of others and Rocabayera Bonvilla et al. in view of Wollmer et al., and Powell et al., are not persuasive.
Regarding rejection under 35 USC 103 over Boyd et al. in view of others:
The applicant argus that the amendment to claim 12 overcomes the rejections of all the claims rejection over Boyd et al. in view of others. The insertion of intended use language categorizing the instantly claimed composition as a topical nasal composition does not overcome the rejections over these references. There is no evidence of record that the topical compositions rendered obvious by Boyd et al. in view of others could not be applied topically to a nasal surface.
Regarding rejection under 35 USC 103 over Rocabayera Bonvilla et al. in view of others:
The applicant asserts that there are incompatibilities between the ELAH of Rocabayera Bonvilla et al., copper gluconate salt, and the microemulsion composition of Wollmer et al. No specific chemical incompatibility is identified by the applicant, but instead they provide speculation that the microemulsion of Wollmer et al. would not form with ELAH and copper gluconate present. As the rejection notes, Wollmer et al. already contemplate the addition of a variety of antiviral and antibacterial compounds in their composition and there remains no evidence that the ELAH and copper gluconate, as particular varieties of these compounds, would be problematic. The applicant notes formulation parameters that can influence microemulsion stability, but do not provide any evidence that the suggested modification to add of ELAH and copper gluconate would be expected to pose an issue. The applicant argues that the rejection adds a plasticizer to microemulsions of Wollmer et al. as well, but this is incorrect, given that each of the exemplified compositions of Wollmer et al. already contain a claimed plasticizer and solvent at claimed proportions.
The applicant additionally argues that the application of the teachings of Powell et al. require the presence of shellac. The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). The copper salts of Powell are antiviral/antimicrobial in the absence of shellac. Contrary to the applicant’s suggestion, the failure of a composition without shellac to function as a barrier that Powell et al. test does not mean that the aqueous based barrier of Wollmer et al. would also fail to function. The composition of Powell et al. provides a barrier envisioned for application to a nasal surface and an antimicrobial active. The combination of Rocabayera Bonvilla et al. and Wollmer et al. also provide a barrier and an antimicrobial envisioned for application to a nasal surface. The inclusion of an additional antimicrobial active in a composition that is antimicrobial is obvious, absent evidence of an unexpected outcome. There remains no evidence of record that an unexpectedly superior outcome results from the combination ELAH and copper gluconate in a topical composition.
The applicant also argues that the overall between the instantly claimed range and the range taught for the copper salt concentration of Powell et al. is not enough overlap to render the range given that they exemplify a concentration outside the claimed range. The applicant’s argument is based upon a consideration of the anticipation of ranges due to overlap with the prior art, discussed in Atofina v. Great Lakes Chem Corp, 441 F.3d 991, 999, 78 USPQ2d 1417, 1423 (Fed. Cir. 2006), and not the obviousness consideration that was set forth in the rejection. Contrary to the applicant’s argument, there is no requirement that a concentration be provided in a “teaching example” in a prior art reference in order for its presence in a taught range to be applicable in an obviousness rejection (see MPEP 2144.05(I).
The applicant additionally argues that Powell et al. teach their composition for treating a condition in cows. While true, they also teach treating a number of conditions in humans and viruses in humans. Contrary to the applicant’s characterization, Powell et al. teach much more than a general statement that the composition can be applied topically to humans. Instead they list several human viruses and wound conditions to treat as well as numerous human treatment locales.
In contrast to the applicant’s argument, Powell et al. do not need to teach the combination of ELAH with copper gluconate in order to support the addition of copper gluconate to a ELAH antiviral/antimicrobial composition. Their teachings do not have to suggest the claimed combination when the rejection relies upon a combination of teachings. Copper is well known antimicrobial metal ion and there is no evidence that any particular salt amongst those known to be employed in this capacity performs any better than any other when paired with ELAH. Thus the evidence of record still supports its utility in combination with ELAH as topical antimicrobial actives. The applicant appears to put forth the teaching-suggestion-motivation rationale as the sole set of valid reasonings to support an obviousness rejection. As the rejection sets forth, the combination of two components known for the same purpose is an obvious modification (see MPEP 2144.06).
The applicant goes on to argue that none of the references teach SARS-CoV-2. Such a teaching is not necessary to render the claimed product or a claimed method obvious. Effectiveness of the claimed composition against SARs-CoV-2 is an intended use and is functionality linked to the presence of copper gluconate and ELAH. The claimed method does not require a patient population that is infected with SARS-CoV-2, but instead requires a person at risk of infection with SARS-CoV-2. This population of patients is no different than those acted upon by Rocabayera Bonvilla et al. Further, identification of properties in a composition that was known or was otherwise obvious does not make the composition newly patentable. While it is true that there were failures in attempts to clinically treat SARS-CoV-2, clinical treatment is not the requirement of the claimed method. Instead, any degree of inhibition is sufficient to meet the instant claim limitations. The application density for an antiviral impact in the treatment locale that the applicant claims was already taught for a composition with ELAH, as detailed by Rocabayera Bonvilla et al. There is no evidence of an unexpectedly superior improvement in efficacy against SARS-CoV-2 due to the addition of copper gluconate or due to formulation of the composition as a microemulsion as opposed to another topical form. The applicant also has provided no evidence of the criticality of the claimed concentration components relative to the impact of SARs-CoV-2 such that within the scope of obvious compositions a subset is particularly suited to addressing this particular virus (e.g., no nexus between the difference between the prior art and the claims and the purported unexpected outcome). The applicant noting the utility of an obvious composition relative to a different respiratory virus than Rocabayera Bonvilla et al. assessed does not make the claimed method unobvious (see MPEP 2145 II).
The applicant points to various administration routes that Rocabayera Bonvilla et al. detail, but none of these options negate their teaching of topical nasal application of ELAH. In contrast to the applicant’s argument, recognition of the ACE2 binding routes of SARS-CoV-2 are irrelevant to the expectation that the composition of Rocabayera Bonvilla et al. when applied topically to the nasal cavity would have been expected to inhibit viral infection in this location to some degree. The applicant appears to argue of the importance of surface localization of the claimed antiviral active compounds, given their argument against the absorption they presume occurs via other administration routes of Rocabayera Bonvilla et al. There is no evidence that surface residence times are critical in an unexpected manner.
The applicant points to Thacore et al. (previously cited) as demonstrating an unpredictable result. The applicant argues that obviousness requires a method to yield no more than predictable results. As MPEP 2145II notes “[t]he recitation of an additional advantage associated with doing what the prior art suggests does not lend patentability to an otherwise unpatentable invention. The breadth of the claims does not require the purposeful attempt to inhibit SARS-CoV-2 infection in order to be practiced because Rocabayera Bonvilla et al. seek to address various strains of influenza in effort to address outbreaks and these patient populations are the same. Thus embodiments of the claimed method remain obvious.
Conclusion
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.
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/CARALYNNE E HELM/Examiner, Art Unit 1615
/MELISSA S MERCIER/Primary Examiner, Art Unit 1615