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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on August 19, 2025 has been entered.
Election/Restrictions
To summarize the applicant's elect, the election of Group II was made with traverse.
Claim 1 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim Objections
Claims 8, 50-51, and 53-58 are objected to because of the following informalities:
The abbreviation NOx should follow its corresponding full name at its first occurrence in claim 8.
Claims 50-51 and 53-58 recite “composition of claims”, but only a singular claim follows the recitation (e.g., change “claims” to “claim”).
Claim 54 recites options for the one or more organic polyol that are two listings, where the second listing repeats all the options from the first listing along with additional choices. The claim would be clearer if a single listing were recited.
Appropriate correction is required.
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 8 and 48-58 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 8 recites a proton source and lists acids as components. The proton source is in an aqueous solution, but it is not recited to be in solution or dissolved. Dependent claim 51 recites options for the proton source, that are themselves solid compounds, where several are also insoluble in water (e.g., polylactic acid and polyglycolic acid) or are required to be in gel form, implying the proton source does not need to be dissolved in the aqueous solution. pH is a property of liquids and liquid based gels. It is then confusing to recite the proton source to have a pH because it is not clear if the recitation is intends to implicitly mean that the proton source is dissolved. A similar issue occurs in claim 53 and in a similar recitation in claim 50 which recites that the nitrite salt is buffered. It would be clearer to recite that “the pH of the aqueous solution is buffered” or alternatively that “the proton source is present as a buffered aqueous solution of the one or more acid”, depending on which meaning the applicant intends for the proton source.
Regarding claim 52, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claims 56 and 58 recite a molar concentration of any one or more organic polyol and nitrite ion in the aqueous solution, but these components were not required to be in an aqueous solution in the parent claim. Thus the recitations lack proper antecedent basis.
Claim 58 recites limitations about the behavior of the proton source under several different method of use situations at a specified points in time. The claim is drawn to a product and not a method. It is not clear what structure is required for the product to meet these situational limitations. For example, the impact of the recitation “the pH of the proton source before, initiation of the NOx generate reaction, is in the range 5.0 to 8.0” on the product structure is not clear. The solution in which the proton source resides could have a pH in this range early in production and the addition of other components could move it outside the range. There is no clear distinction between a composition that traversed the claimed pH range during processing and one that did not, when both have the same final components prior to reaction initiation. Thus the impact of these limitations on the claimed product are unclear. Also different pH ranges are recited for different intended uses. The way in which one thinks about potentially employing a product in the future provides a moving set of limitations that cannot consistently be met or avoided. For the sake of application of prior art, compositions that meet the recited structural limitations of claim 58 will be deemed sufficient to meet these limitations as well. Clarification is still required.
Claims not explicitly expounded upon are also indefinite because they depend from an indefinite claim and do not add clarity.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 54 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
The parent claim of claim 54 recites that the organic has 4, 5, 6, 7, 8, , 10, 11, or 12 carbons. Claim 54 then recites that the organic polyol is selected from a listing that includes glycerol which has 3 carbons and falls outside the scope of the parent claim.
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 8 and 48-58 are rejected under 35 U.S.C. 103 as obvious over Nie et al. (previously cited) in view of Porter (previously cited) and Arvidsson et al. (US PGPub No. 2014/0350120) as evidenced by Yu et al. (CN 1698584 – English translation relied upon for citations), Lin et al. (WO 2008/066810), Surber et al. (US PGPub No. 2009/0196930), and Alimi et al. (US PGPub No. 2006/0235350).
Nie et al. teach compositions for treating skin ulcer wounds that provide antimicrobial properties (see paragraphs 2 and 13-14; instant claim 8). They prepare a kit composed of part A and part B that generate nitric oxide when they are mixed (see paragraph 14; instant claim 8). The final composition includes water (aqueous carrier), sodium nitrite (alkaline metal nitrite salt), ascorbic acid (proton source, non-carboxylic acid reducing acid), a gel matrix, a transdermal absorption enhancer, preservative, Tween® 80 (solubilizer), and a humectant/moisturizer which is one or two of glycerin, sorbitol (6 carbon sugar alcohol, 6 carbon alditol), propylene glycol and polyethylene glycol (see paragraphs 13 and 31; instant claims 8, 48, 51-54, and 57-58). The composition is prepared by first making part A as a solution of sodium nitrate (nitrite salt) and moisturizer/humectant to which transdermal absorption enhancer and gel matrix are added (see paragraphs 18-23). Part B is made as a solution of ascorbic acid, base, and moisturizer/humectant in water to which is added gel matrix, transdermal absorption enhancer, and other desired ingredients (see paragraphs 24-28). An example provides part A as sodium nitrite in about 90 wt% water along with azone as a permeation enhancer, glycerin at 5 wt%, and hydroxyethylcellulose as a gelling agent/matrix at 1 wt% and part B as ascorbic acid (proton source, non-carboxylic acid reducing acid) dissolved in about 80 wt% water along with glycerin at about 5 wt% and hydroxyethyl cellulose as a gelling agent/matrix at 1 wt% (see paragraphs 18-30 and example 1; instant claims 49, 52, and 55). This example provides the acid proton source, the polyol, and nitrite dissolved in aqueous solution (see instant claims 8, 53, 55). Example 5 is detailed as recapitulating example 1 except glycerin is replaced with sorbitol (6 carbon straight chain sugar alcohol, 6 carbon alditol), propylene glycol, or polyethylene glycol (see paragraph 48; instant claims 8, 54, and 58). A 1:1 mixing ratio of part A and part B is taught and yields an easily applied gel form (see paragraphs 16 and 88). The presence of a buffer is not explicitly detailed.
Porter teaches an ascorbic acid (vitamin C) containing topical composition (see abstract). They detail that the acid can be irritating to skin and teach the inclusion of a buffer to adjust the composition pH to a skin compatible level (see column 8 lines 40-65). A pH range of 4 to 7 is preferable (see column 8 lines 46-47).
Arvidsson et al. teach eugenol as an alternative topical permeation enhancer to azone (see paragraph 29).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include sorbitol in place of glycerin as Nie et al. detail because Nie et al. explicitly state to do so. The result is a nitric oxide producing mixture with 10 g sorbitol, 2 g sodium nitrite, and 8 g ascorbic acid which corresponds to a molar ratio of organic polyol to nitrite ion of 1.8 and organic polyol to proton source of 1.21 (as calculated by the examiner; see instant claims 56 and 58). It additionally would have been obvious to add a buffer to the composition of Nie et al. and adjust its pH in light of Porter to make the ascorbic acid containing composition skin compatible. The exemplified composition already recites a base as a component, which further supports obviousness of adjusting the pH upward. The range of pH values overlap with those 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). Including the buffer in part B with the ascorbic acid proton source or in the final preparation would have been obvious because they are two of the three options for placement locations for ingredients and are the location of the ascorbic acid. Choosing from a finite number of identified predictable options is obvious. It additionally would have been obvious the exchange eugenol for the azone as a recognized alternative skin penetration enhancers, in light of Arvidsson 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.
The instant claims recite a composition that is inhalable using a nebulizer. This is an intended use. In order for an intended use claim recitation to patentably distinguish the claimed invention from the prior art, it must result in a structural difference between the claimed invention and the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Yu et al. teach a gel composition that is able to be atomized and sprayed into the nose for drug delivery (see paragraphs 2 and 6-7). They envision gelling agents that include hydroxypropyl cellulose which is the gelling agent in the exemplary compositions of Nie et al. (see paragraph 17). The proportion of this component is envisioned at up to 5 wt% which is higher than that used by Nie et al. and implies that the gel of Nie et al. can also be atomized (see paragraph 25). Eugenol and sorbitol as well as surfactants are taught by Lin et al. as envisioned components in a pulmonary composition, indicating their suitability for inhaled administration (see paragraph 56). Surber et al. teach aerosolized sodium nitrite for inhaled administration of nitric oxide via combination with an acid via nebulizer (see abstract and paragraphs 38 and 58). Further, Alimi et al. teach that gel compositions envisioned for topical application can be aerosolized via nebulizer (see abstract and paragraphs 71-72). Thus the composition of Nie et al. in view of Porter et al. and Arvidsson et al. can be nebulized and its ingredients can be inhaled, thereby meeting the instant limitation of being inhalable using a nebulizer. The named microbe targets in instant claim 58 are also intended use limitations that depend upon the active agent that is included. The composition rendered obvious generates nitric oxide, therefore it is capable of providing some degree of treatment to the an infection. Therefore claims 8 and 48-58 are obvious over Nie et al. in view of Porter et al. and Arvidsson et al. as evidenced by Yu et al., Lin et al., Surber et al., and Alimi et al.
Claims 8 and 48-57 are rejected under 35 U.S.C. 103 as being unpatentable over Willey et al. (previously cited) in view of O’goshi et al. (Skin Research and Technology 2006 12:155-161) as evidenced by Taylor (previously cited), Yu et al., Lin et al., Surber et al., and Alimi et al.
Willey et al. teach a gas transmitting composition (see abstract). A topical nitric oxide generating version is exemplified to contain sodium nitrate (alkaline metal nitrite salt), pH modifying excipient (buffer), electrochemical mediator in the form of quinone and phenone compounds, glycerol at 10 wt%, water, and Carbopol® 974P (hydrogel comprising pendant carboxylic acid groups covalently bonded to a three-dimensional polymeric matrix; proton source), where the mixture has a pH of 7 (see table 1 samples A-B; instant claims 8 and 48-55). Sodium nitrate is water soluble and present at 1 wt% or 3 wt% in these preparations that include about 85 wt% water and 1 wt% or 0.3 wt% Carbopol® 974P (see paragraph 13). Thus the proton source is present in a solution that is buffered to pH 7 which also buffers the proton source (see instant claims 8, 50, and 53). The composition is generally taught to include a polyhydric alcohol that is envisioned as glycerol as well as sorbitol (6 carbon sugar alcohol) (see paragraph 56; instant claims 8 and 54). 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 8). They teach nitric oxide releasing compositions as antimicrobial (see paragraph 3; instant claim 8). The quinone and phenone compounds are options for the water electrochemical mediator that is also envisioned as a fluorescein (see paragraphs 33-34 and claim 39). Willey et al. further teach that anti-inflammatory agents and various other pharmaceutical actives may be included in the composition (see paragraphs 70101-102; instant 57). A particular water soluble fluorescein is not detailed.
O’goshi et al. teach sodium fluorescein as a water soluble fluorescein considered to be suitable for topical application due to its suitable (see abstract and page 156 first column second full paragraph).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to exchange sorbitol for the glycerol 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. The resulting 10 wt% proportion of sorbitol would correspond to a molar concentration of 0.5 M and a 1 wt% sodium nitrite of sample A would correspond to a molar concentration of 0.2 M nitrite ion; thus the polyol would be present at about 2.5 times the molar concentration of the nitrite ion (as calculated by the examiner; see instant claims 49 and 55-56). It additionally would have been obvious to exchange a water soluble fluorescein for the electrochemical mediator compounds for the same reason. The selection of sodium fluorescein as the compound would have been obvious in light of O’goshi et al. who teach its suitability for topical compositions. It further would follow to include a pharmaceutical active as Willey et al. teach (see instant claim 57).
The instant claims recite a composition that is inhalable using a nebulizer. This is an intended use. In order for an intended use claim recitation to patentably distinguish the claimed invention from the prior art, it must result in a structural difference between the claimed invention and the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Yu et al. teach a gel composition that is able to be atomized and sprayed into the nose for drug delivery (see paragraphs 2 and 6-7). They envision gelling agents that include Carbomer®, which is another name for the polymer employed by Willey et al. (see paragraph 17 and Taylor et al. paragraph 28). The proportion of this component is envisioned at up to 5 wt% which is higher than that used by Willey et al. and implies that the gel of Willey et al. can also be atomized (see paragraph 25). Sorbitol is taught by Lin et al. as an envisioned component in a pulmonary composition, indicating its suitability for inhaled administration (see paragraph 56). Surber et al. teach aerosolized sodium nitrite for inhaled administration of nitric oxide via combination with an acid via nebulizer (see abstract and paragraph 38). Further, Alimi et al. teach that gel compositions envisioned for topical application can be aerosolized via nebulizer (see abstract and paragraphs 71-72). Thus the composition of Willey et al. in view of O’goshi et al. can be nebulized and its ingredients can be inhaled, thereby meeting the instant limitation of being inhalable using a nebulizer. Therefore claims 8, 48-52, 54-55, and 57 are obvious over Willey et al. in view of O’goshi et al. as evidenced by Taylor, Yu et al., Lin et al., Surber et al., and Alimi 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.
Claims 8 and 48-58 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable 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 the copending claims recite a composition composed of a buffer, water, and nitrite salt where the pH is 4.6 to 6. The composition also includes particular nitrite salts, polyols, and organic carboxylic acids and organic non-carboxylic reducing acids in accordance with the instant claims. The nitrite salt molarity meets the instant claim limitations. A buffer component is citric acid and its molarity meets the limitations of the proton source molarity instantly claimed. In addition, ascorbic acid is also a named organic non-carboxylic reducing acid. The copending product claims recite the composition to be an antimicrobial composition for treating respiratory conditions.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the members of the recited categories of components in the copending claims, because they recite to do so. Necessary selections of amounts of each component and routine work by the artisan of ordinary skill in light of the concentration teachings render the claimed ratios and concentrations obvious. The pH range overlaps with that instantly claimed, thereby rendering it obvious as well (see MPE 2144.05). The instant claims recite a composition that is inhalable using a nebulizer. This is an intended use. In order for an intended use claim recitation to patentably distinguish the claimed invention from the prior art, it must result in a structural difference between the claimed invention and the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The liquid composition of the copending claims can be nebulized, is inhalable, and is envisioned as a respiratory treatment. Thus the claimed intended use is met. Therefore claims 8 and 48-58 are obvious over claims 1-31 of copending Application No. 19/156193.
Claims 8 and 48-58 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable 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 the copending claims recite a composition composed of a buffer, water, and nitrite salt where the pH is 4.6 to 6. The composition also includes particular nitrite salts, polyols, and organic carboxylic acids and organic non-carboxylic reducing acids in accordance with the instant claims. The nitrite salt molarity meets the instant claim limitations. A buffer component is citric acid and its molarity meets the limitations of the proton source molarity instantly claimed. In addition, ascorbic acid is also a named organic non-carboxylic reducing acid. The copending product claims recite the composition to be an antimicrobial composition for treating respiratory conditions.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the members of the recited categories of components in the copending claims, because they recite to do so. Necessary selections of amounts of each component and routine work by the artisan of ordinary skill in light of the concentration teachings render the claimed ratios and concentrations obvious. The pH range overlaps with that instantly claimed, thereby rendering it obvious as well (see MPE 2144.05). The instant claims recite a composition that is inhalable using a nebulizer. This is an intended use. In order for an intended use claim recitation to patentably distinguish the claimed invention from the prior art, it must result in a structural difference between the claimed invention and the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The liquid composition of the copending claims can be nebulized, is inhalable, and is envisioned as a respiratory treatment. Thus the claimed intended use is met. Therefore claims 8 and 48-58 are obvious over claims 1-31 of copending Application No. 19/156193.
Claims 8 and 48-58 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of copending Application No. 19/156233 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims recite a composition composed of a buffer, water, and nitrite salt where the pH is 3.8 to 6. The composition also includes particular nitrite salts, polyols, and organic carboxylic acids and organic non-carboxylic reducing acids in accordance with the instant claims. The nitrite salt molarity meets the instant claim limitations. A buffer component is citric acid and its molarity meets the limitations of the proton source molarity instantly claimed. In addition, ascorbic acid is also a named organic non-carboxylic reducing acid. The copending product claims recite the composition to be an antimicrobial composition for treating respiratory conditions.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the members of the recited categories of components in the copending claims, because they recite to do so. Necessary selections of amounts of each component and routine work by the artisan of ordinary skill in light of the concentration teachings render the claimed ratios and concentrations obvious. The pH range overlaps with that instantly claimed, thereby rendering it obvious as well (see MPE 2144.05). The instant claims recite a composition that is inhalable using a nebulizer. This is an intended use. In order for an intended use claim recitation to patentably distinguish the claimed invention from the prior art, it must result in a structural difference between the claimed invention and the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The liquid composition of the copending claims can be nebulized and is inhalable. Thus the claimed intended use is met. Therefore claims 8 and 48-58 are obvious over claims 1-29 of copending Application No. 19/156233.
These are provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant's arguments filed August 19, 2025 have been fully considered. In light of the amendment to the claims some rejection under 35 USC 112 have been withdrawn. Those that remain are maintained. New grounds of rejection under 35 USC 112 and 35 USC 103 are detailed that address the new claim limitations.
Conclusion
No claim is allowed.
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/CARALYNNE E HELM/Examiner, Art Unit 1615