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 .
Means-Plus-Function Interpretation
Claim 70 recites “at least one device or other means for controlled mixing of the components and dispensing the reaction mixture, one or more components thereof and/or the evolved gas out of the dispenser and direct it to a target”.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Claim Objections
Claim 68 is objected to because of the following informalities: the recitation “mannitol or any combination of mannitol with one or more of…” goes on to list mannitol as an option for combination with mannitol. This added recitation of mannitol is redundant. Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-6, 66-69, 71, 73-74, and 76 are rejected under 35 U.S.C. 102(a)(1) as anticipated by Tawashi (previously cited).
Tawashi discloses a nitric oxide producing water dissolvable tablet that is dissolved in water and generates nitric oxide (see abstract and example 2). The tablet is composed of citric acid (proton source, not a hydrogel comprising pendant carboxylic acid groups covalently bonded to a three dimensional polymeric matrix), sodium nitrite (alkali metal salt), mannitol (six carbon sugar alcohol), and other excipients (see instant claims 1-6, 67-69, 71, 74, and 76). A composition “consisting essentially of” a set of components excludes components that adversely affect the claimed components (see instant specification page 9 lines 30-36). A limiting definition is not detailed for the permissible proportion of unclaimed ingredients that do not adversely affect the composition; therefore the dissolved composition of Tawashi meets the limitations of instant claim 66. The citric acid, sodium nitrite, mannitol are present at a molar ratio of about 1:2:13 which provides the mannitol well in excess of the 1:1:0.5 molar ratio instantly exemplified as providing a reaction enhancing amount of polyol (see instant specification example 2, experiment D and figure 5; as calculated by the examiner; instant claims 2 and 4). The tablet excipients compose 24 wt% of the tablet. While the amount of water in which the tablet is dissolved is not detailed, regardless of its quantity, the resulting combination would have the excipients in solution in an aqueous carrier and present at a proportions less than about 20 wt% of the resulting combination because their 24 wt% in the tablet meet the limitations of about 20 wt% or less of the tablet (see instant claim 73). Therefore claims 1-6, 66-69, 71, 73-74, and 76 are anticipated by Tawashi.
Claim Rejections - 35 USC § 102/103
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
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.
Claims 1-4, 66-69, 71, 74, and 76 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Bryan et al. (previously cited).
Bryan et al. disclose a nitric oxide generating composition in various forms (see abstract and paragraph 55). A lozenge dissolvable in the mouth that is dissolved in saliva is detailed, explicitly or implicitly, via the administration of the lozenge to a man (see paragraph 78). The lozenge components include mannitol (six carbon sugar alcohol; polyol), xylitol (five carbon sugar alcohol; polyol), ascorbic acid (organic non-carboxylic reducing acid; (proton source, not a hydrogel comprising pendant carboxylic acid groups covalently bonded to a three dimensional polymeric matrix), sodium nitrite (alkali metal nitrite salt) and excipients (see paragraphs 69-70 and 78, instant claims 1-4, 67-69, 71, 74, and 76). A composition “consisting essentially of” a set of components excludes components that adversely affect the claimed components (see instant specification page 9 lines 30-36). A limiting definition is not detailed for the permissible proportion of unclaimed ingredients that do not adversely affect the composition; therefore the saliva dissolved composition of Bryan et al. meets the limitations of instant claim 66. Upon dissolution of the lozenge in the saliva, the reactive components of the lozenge would react and generate nitric oxide. Either the treated man consumed the dissolvable lozenge as intended where it fully dissolved in the mouth, or it would have been obvious to administer it in this way to one of ordinary skill in the art before the effective filing date of the claimed invention because that is the intended use. Therefore claims 1-4, 66-69, 71, 74, and 76 are anticipated by or obvious over Bryan et al.
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 1-6, 66-69, 71, 74, and 76 are rejected under 35 U.S.C. 103 as being unpatentable over Bryan et al. in view of St. Cyr et al. (US PGPub No. 2012/0045426)
Bryan et al. teach nitric oxide generating composition in various forms (see abstract and paragraph 55). The lozenge components include mannitol (six carbon sugar alcohol; polyol), xylitol (five carbon sugar alcohol; polyol), sodium nitrite (alkali metal nitrite salt), ascorbic acid (proton source, not a hydrogel comprising pendant carboxylic acid groups covalently bonded to a three dimensional polymeric matrix), and excipients (see paragraphs 69-60 and 78; instant claims 1-6, 67-69, 74, and 76). They additionally teach dissolvable powder for dissolution in a beverage (see paragraph 55; instant claims 3-6). Bryan et al. go on to teach weight parts for the categories of components in their composition. They detail nitrite salt at about 20 to 500 weight parts, vitamin C at about 20 to 500 weight parts, and other ingredients that may be mannitol, xylitol, or other sugar alcohols at about 50 to about 1500 weight parts (see paragraphs 39-46).Water is not explicitly taught as the beverage in which the dissolvable powder is dissolved.
St. Cyr et al. teach an oral formulation envisioned to facilitate nitric oxide production amongst other effects in order to increase energy (see abstract and paragraphs 68 and 109). The composition forms are envisioned to include a powder dissolvable in potable liquid to produce a beverage such as water, fruit juice, and coffee (see paragraph 68).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select water as the liquid in which to dissolve the dissolvable powder of Bryan et al. in light of St. Cyr et al. who teach water as a known option for reconstituting such powders for consumption. This choice is obvious as the simple substitution of one known element for another in order to yield a predictable outcome (e.g., specific beverage vs. generic beverage). Since the orally dissolvable lozenge example of Bryan et al. is suitable for oral consumption as it is, it would also be suitable for dissolution in water prior to consumption or to be provided in powder form to be dissolved in a beverage. The beverage resulting from the dissolution of the lozenge/powdered lozenge of Bryan et al. would generate nitric oxide and would provide each of the claimed components in solution form (see instant claims 1, 3, and 66). A composition “consisting essentially of” a set of components excludes components that adversely affect the claimed components (see instant specification page 9 lines 30-36). A limiting definition is not detailed for the permissible proportion of unclaimed ingredients that do not adversely affect the composition; therefore the water dissolved composition of Bryan et al. meets the limitations of instant claim 66. A numerical value for a reaction enhancing amount of polyol is not detailed; however, the applicant exemplifies a molar ratio of nitrite salt to ascorbic acid to polyol of 1:1:1 in experiment C (see instant specification example 2 and figure 4). On a weight basis, this corresponds to a ratio of about 1:2:2 nitrite salt to ascorbic acid to polyol. The ranges of relative amounts of nitrite salt, ascorbic acid, and polyol yield a range of ratios that embrace this ratio, thereby embracing or overlapping with the implied range of a reaction enhancing amount of polyol (see instant claims 2 and 4). “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). Therefore claims 1-6, 66-69, 71, 74, and 76 are obvious over Bryan et al in view of St. Cyr et al.
Claims 1-6 and 65-75 are rejected under 35 U.S.C. 103 as being unpatentable over Willey et al. (previously cited) as evidenced by Taylor (previously cited).
Willey et al. teach a gas transmitting composition (see abstract). A topical nitric oxide generating version is exemplified to contain sodium nitrite (alkali metal nitrite salt), pH modifying excipient or phosphate buffer, electrochemical mediator in the form of quinone and phenone compounds, glycerol, water, and Carbopol® 974P (hydrogel comprising pendant carboxylic acid groups covalently bonded to a three-dimensional polymeric matrix) (see table 1 samples A and B; instant claims 1-6, 65-70, and 75). The composition has water present at greater than 85% as well as excipients (see instant claim 73). A composition “consisting essentially of” a set of components excludes components that adversely affect the claimed components (see instant specification page 9 lines 30-36). A limiting definition is not detailed for the permissible proportion of unclaimed ingredients that do not adversely affect the composition; therefore the saliva dissolved composition of Willey et al. meets the limitations of instant claim 66. The composition is also pH adjusted to 7 (see instant claim 75). Willey et al. further teach the composition to include a polyhydric alcohol that is envisioned as glycerol as well as mannitol (6 carbon straight chain sugar alcohol with 6 OH groups per molecule, organic polyol, not solely glycerol, not solely polyvinyl alcohol) (see paragraph 56; instant claim 1, 3, and 72). Carbopol® 974P is a crosslinked (three dimensional) polyacrylic acid gel which is a hydrogel in water (see Taylor paragraph 29-30 and 32). The exemplary composition is prepared and produces nitric oxide under electrolysis (see paragraph 134-135; instant claim 1). The preparation of the composition implicitly requires a container to hold the ingredients prior to mixing as well as during mixing, given that a liquid is present (see instant claim 70). Willey et al. go on to teach packing the composition in a two compartment package, where the nitrite salt and electrochemical mediator are separate or together and the container may have dispensing cap for dosing (see paragraphs 123-124).
A full example of each embodiment that follows from the teachings of Willey et al. is not detailed; however, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to exchange mannitol for the glycerol polyol in the composition of Willey et al. This modification would have been obvious as the simple substitution of one known element for another in order to yield a predictable outcome. Additionally, there are only two locations for the ingredients in the two compartment container, thus the presence of the Carbopol® 974P and mannitol in separate compartments along with water would have been obvious as one option amongst a small number of finite, identified, predictable solutions, with a reasonable expectation of success (see instant claim 65). Since the final composition has a pH of 7, this outcome can be attained by the compositions in each compartment each being pH 7. In the case of the modified table 1 example B composition, the compositions would also have a phosphate buffer (see instant claim 75). Therefore claims 1-6 and 65-75 are obvious over Willey et al. as evidenced by Taylor.
Claims 1-6, 66-74 and 76 are rejected under 35 U.S.C. 103 as being unpatentable over Nie et al. in view of Pagliuca et al. (previously cited).
Nie et al. teach compositions for treating skin ulcer wounds (see paragraph 2). The composition is a gel kit composed of gel A and gel B that generate nitric oxide when they are mixed (see paragraph 14; instant claims 1-4). The final gel includes sodium nitrite (alkali metal nitrite salt), ascorbic acid (proton source, not a hydrogel comprising pendant carboxylic acid groups covalently bonded to a three dimensional polymeric matrix), a gel matrix, a transdermal absorption enhancer, preservative, Tween® 80 (solubilizer), and a humectant which is envisioned as glycerin, sorbitol, propylene glycol and/or polyethylene glycol (see paragraphs 13 and 31; instant claims 1-6, 66-69, 72, 74, and 76). An example details gel A as containing water, hydroxyethylcellulose, sodium nitrite (nitrite salt), and glycerin and gel B as containing ascorbic acid (proton source, not a hydrogel comprising pendant carboxylic acid groups covalently bonded to a three dimensional polymeric matrix), glycerin, hydroxyethyl cellulose, and water (see example 1; instant claims 3-6). The sodium nitrite is dissolved in water during the course of preparation and gel A and gel B are mixed to produce the treatment composition (see paragraphs 18-30; instant claims 1, 3, and 5). The preparation of the mixture implicitly requires a container to hold the ingredients prior to mixing as well as during mixing, given that a liquid is present (see instant claim 70). Mannitol is not explicitly named as a humectant.
Pagliuca et al. teach a skin patch for the delivery of a desired pain reducing active (see abstract). The composition includes a humectant envisioned as a polyalcohol selected from mannitol, glycols, and sorbitol (see paragraph 15).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to exchange mannitol for the glycerin in the example of Nie et al. in light of Pagliuca et al. This modification is obvious as the simple substitution of one known element for another in order to yield a predictable outcome. A composition “consisting essentially of” a set of components excludes components that adversely affect the claimed components (see instant specification page 9 lines 30-36). A limiting definition is not detailed for the permissible proportion of unclaimed ingredients that do not adversely affect the composition; therefore the gel composition of Nie et al. meets the limitations of instant claim 66. The modified composition of Nie et al. example 1 also results in a nitric oxide producing reaction mixture/combination with less than 20 wt% excipients other than the claimed components (see instant claim 73). Therefore claims 1-6, 66-74 and 76 are obvious over Nie et al. in view of Pagliuca et al.
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.
The following are provisional nonstatutory double patenting rejections because the patentably indistinct claims have not in fact been patented.
Claims 1-6, 66-71, and 73-76 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 and 19-30 of copending Application No. 19/156233 (reference application) and over claims 1-31 of copending Application No. 19/156193 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because sets of claims recite a therapeutic liquid nitric oxide generating composition and kit composed of a nitrate salt and one or more organic polyol and an aqueous solution of one or more acid selected from organic carboxylic acids and organic non-carboxylic reducing acids. The organic polyol is a sugar alcohol recited as mannitol, the nitrate can be various alkali metal salts, and the organic carboxylic acid may be citric acid at a concentration whose range meets the instant limitations and has a solution pH that overlaps the instant range. a solution preparation is detailed (see MPEP 2144.05). While a single lineage of claims is not detailed that provides for each of the claims limitations, it would have been obvious artisan of ordinary skill in the art before the effective filing date of the claimed invention to select recited options for component concentrations and pH levels as well as particular recited options for the nitrite salt and polyol because the copending claims recite to do so. The copending claims recite a method of generating nitric oxide by combining the recited components. Thus claims 11-6, 66-71, and 73-76 are obvious over claims 1-17 and 19-30 of copending Application No. 19/156233 and over claims 1-31 of copending Application No. 19/156193.
Response to Arguments
Applicant's arguments filed January 23, 2026 have been fully considered. In light of the amendment, the objection and the rejection under 35 UC 112(b) are hereby withdrawn. The arguments against the remaining rejections are not persuasive.
Regarding the rejection under 35 USC 102 over Tawashi et al.:
The applicant argues that Tawashi et al. do not teach their proportion of mannitol to be a reaction output enhancing amount when they describe the presence of mannitol as a conventional filler or excipient. The difference between the collection of adjectives chosen by Tawashi et al. to describe their polyol, mannitol, and the applicant’s chosen adjectives for its polyol that is recited as mannitol does not change the function of the polyol. There is no evidence demonstrating that the amount of mannitol present in the tablet of Tawashi et al. does not meet the limitation of being a reaction output enhancing amount. The applicant chose to employ functional, capability based language to describe the amount of mannitol in its composition instead of a numerical value, as is their prerogative. However this selection does not confer new or different properties onto the polyol.
As a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith. In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972). Moreover, MPEP 2112.01 details that, “[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.” This treatment results from In re Spada, which states that, “Products of identical chemical composition can not have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A product with a “reaction output enhancing amount” of organic polyol has organic polyol in an amount that can, under some circumstance, enhance the amount or duration of nitric oxide, optionally other oxides of nitrogen and/or optionally precursors thereof from the NOx generating reaction to be higher than if the reaction had been performed under the same conditions but without the organic polyol (see instant specification page 13 lines 4-8). The fact that the “reaction output enhancing amount” recitation is describing capabilities of the polyol amount and does not require an increase in nitric oxide under all reaction conditions in order to be fulfilled is illustrated by the instant disclosure. Here, the instant specification details that the differential nitric oxide production that the claimed organic polyol can produce is pH dependent, such that a single composition with an organic polyol enhanced nitric oxide produced at pH 3 and 4.8 but not at pH 6.8, as compared to the same composition without the organic polyol (see figures 11-14). The composition had a “reaction output enhancing amount”, but only produced an enhanced amount of nitric oxide under certain circumstances, as compared to a composition without the polyol. In the context of the claimed method for generating nitric oxide, the reaction is not required to produce more nitric oxide than a comparative reaction without organic polyol, but instead the organic polyol is to be present at a “reaction output enhancing amount”. This is, once again, a recitation of organic polyol quantity based upon its capability. Stoichiometry, pH, and concentration govern the nitric oxide reaction. The exemplary composition of Tawashi et al. provides stoichiometric ratios of nitrite and citric acid as instantly exemplified that are able to produce nitric oxide and includes mannitol as an organic polyol at a higher molar proportion than instantly required (see instant example 2). Chosen reaction/dissolution conditions control the concentration and pH. There is no indication of a deleterious effect of having excess organic polyol on the generation of nitric oxide (e.g., an amount beyond which enhancement of nitric oxide product under appropriate acidic conditions ceases to occur under some condition) from the reaction of nitrite and the carboxylic acid, citric acid. Thus it remains the position of the examiner that the exemplified composition of Tawashi et al. and its dissolution in water fulfills the limitations of the claimed composition and method.
Regarding the rejection under 35 USC 102/103 over Bryan et al. and under 35 USC 103 over Bryan et al. in view of Sy. Cyr et al.:
The applicant argues that Bryan et al. do not teach their amount of polyol in their nitrite and carboxylic acid containing composition to be a “reaction output enhancing amount”. The same argument was detailed against the teachings of Tawashi et al. The response to this argument in the preceding paragraph is similarly reiterated. The amount of nitrite and ascorbic acid in Bryan et al. are sufficient to produce nitric oxide and there is no evidence than any particular amount of mannitol is necessary to yield a reaction output enhancing amount in their presence.
The applicant further argues that there is insufficient motivation to combine the teachings of Bryan et al. and St. Cyr et al. To the contrary, both references detail dissolvable powder compositions that are formed into a beverage that induces nitric oxide generation. While the former provides its own reactants and latter acts upon cells in the subject, this distinction does not negate the utility of the same sort of beverage vehicles for delivering their compositions in order to product nitric oxide.
The applicant goes on to argue that the claimed composition provides unexpectedly superior results. This argument is based upon data in the instant disclosure that shows that the presence of a polyol along with nitrite and carboxylic acid in a composition increases the generation of nitric oxide as compared to the same composition under the same reaction conditions without the polyol. This difference between the instant composition and the comparative composition is not reflective of a difference between the prior art and the claimed invention. Bryan et al. already includes mannitol as a polyol in their composition with nitrite and a carboxylic acid. There is no evidence that the amount of mannitol in the composition of Bryan et al. is not a “reaction output enhancing amount”
Regarding the rejection under 35 USC 103 over Willey et al.:
The applicant argues that Willey et al. do not teach their amount of polyol in their nitrite and carboxylic acid containing composition to be a “reaction output enhancing amount”. The same argument was detailed against the teachings of Tawashi et al. The response to this argument detailed previously in this section is similarly reiterated. The applicant also argues that the nitric oxide generation occurs in Willey et al. due to electrochemical reduction at an electrode and not via the nitrite reacting with an acidic protein source. The aqueous composition of Willey et al. contains both nitrite and a hydrogel with pendant carboxylic acid groups, as instantly claimed. There is no evidence provided by the applicant that these components do not react with one another nor a reason provided for why these components would not be expected to react.
The applicant also argues that the exchange of mannitol for the exemplified glycerol does not yield a “reaction output enhancing amount” of the mannitol. Again, the applicant has provided no evidence that the proportion of polyol in the exemplified composition of Willey et al. when provided by mannitol is insufficient to yield a reaction output enhancing amount.
Regarding the rejection under 35 USC 103 over Nie et al.:
The applicant argues that Nie et al. do not teach their amount of polyol in their nitrite and carboxylic acid containing composition to be a “reaction output enhancing amount”. The same argument was detailed against the teachings of Tawashi et al. The response to this argument detailed previously in this section is similarly reiterated. Again, the applicant has provided no evidence that the proportion of humectant in the exemplified composition of Nie et al. when provided by mannitol or glycerol is insufficient to yield a reaction output enhancing amount.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CARALYNNE E HELM whose telephone number is (571)270-3506. The examiner can normally be reached Mon-Fri 9-5.
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/CARALYNNE E HELM/Examiner, Art Unit 1615
/MELISSA S MERCIER/Primary Examiner, Art Unit 1615