DETAILED ACTION
Background
The amendment dated September 30, 2025 (amendment) amending claims 1-3 has been entered. Claims 1-3 as filed with the amendment have been examined. Claims 4-6 and 8-11 have been withdrawn from consideration. Claim 7 has been canceled. In view of the amendment, all outstanding claim objections have been withdrawn.
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 .
Claim Objections
Claims 1 and 3 are objected to because of the following informalities:
In claim 1, at line 2 after “0.70 wt.%” insert a comma --,--;
at line 3, after “ppm weight” insert a comma --,--;
at line 5 after “ppm weight” insert a comma --,--;
at line 6 after “ppm weight” insert a comma --,--;
at line 7 after “0.2 wt.%” insert a comma --,--;
at line 11 after “ppm weight” insert a comma --,--;
at line 12, after “0.35 wt.%” insert a comma --,--;
at line 13, after “nitrite,” delete [[and]];
at line 14 after “100.5 wt.%” insert a comma --,--; and,
at line 15 after “nitrite;” insert -- and,--;
In claim 3, at line 2 after “ppm weight” insert a comma --,--;
at line 3 after “ppm weight” insert a comma --,--; and,
at line 5 after “ppm weight” insert a comma --,--.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 are rejected under 35 U.S.C. 103 as being unpatentable over EP 0754651 A1 to Juergen (Juergen).
All references to Juergen refer to the Clarivate machine translation, a copy of which was included in a previous Office action.
Unless otherwise indicated, all disclosed %s without units are interpreted as weight %, and weight % and mass % are interpreted as interchangeable.
Regarding instant claim 1, Juergen at the Abstract on page 1 discloses a sodium nitrite made pourable in by coating it with silicic acid and/or tricalcium phosphate (an “anticaking agent”). Juergen at the paragraph bridging pages 2 and 3 discloses free-flowing sodium nitrite in such a purity that it meets the requirements of the food industry (”free-flowing food grade sodium nitrite”). Further, at page 3, 5th full paragraph Juergen discloses a residual moisture content (“loss on drying” as a %) of the free-flowing food grade sodium nitrite composition of less than 0.2 % by weight of water. Still further, at page 3, 7th full paragraph Juergen discloses the added coating substance or anticaking agent in the amount of 0.2 to 0.4% by weight, based on the total composition, within which range lies the claimed “0.25-0.35%” of anticaking agent. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art", the Office considers that a prima facie case of obviousness exists. See MPEP 2144.05.I. The ordinary skilled artisan in Juergen would have found it obvious to include the claimed amount of anticaking agent because Juergen discloses that the claimed amount of the anticaking agent is desirable for making a free-flowing food grade sodium nitrite.
Further regarding instant claim 1 and regarding instant claims 2 and 3, Juergen at the Description in the paragraph bridging pages 1 and 2 discloses making a synthetic sodium nitrite by reacting a nitrous acid gas with a sodium hydroxide solution. The Office considers the sodium nitrite made by the stoichiometric reaction of nitrous acid gas, a strong acid gas with sodium hydroxide, a strong base as disclosed in Juergen to produce a virtually 100% pure composition of sodium nitrite and water, thereby making the sodium nitrite substantially devoid of any impurity. The Office thus considers the claimed free-flowing food grade sodium nitrite and the dried, free-flowing food grade sodium nitrite coated in an anticaking agent as disclosed in Juergen to be substantially the same thing. Accordingly, absent a clear showing as to how the content of the dried, free-flowing food grade sodium nitrite of Juergen differs from that of the free-flowing food grade sodium nitrite as claimed, the Office considers the pure, dried free-flowing food grade sodium nitrite of Juergen as disclosed in the paragraph bridging pages 1 and 2 and at page 3, 5th and 7th full paragraph to have all of the amount of NaNO3 of no greater than 0.70%, alkalinity as Na2CO3 of no greater than 600 ppm, a chloride content of no greater than about 50 ppm, a sulphate content of no greater than 50 ppm, a content of insolubles of no greater than 0.4%, a content of a heavy metal of no greater than 10 ppm, a content of heavy metal cadmium (cd) of no greater than 1 ppm, a content of anticaking agent of between 0.25-0.35%, a content of assay of within a range of 98.5% to 100.5%, and wherein the purity of the free-flowing food grade sodium nitrite is about 99.0- 99.9% as claimed in claim 1; further, to have the low heavy metal content which is at least lead (Pb) as in claim 2, which includes zero ppm lead; and, still further, to comprise comprising a content of arsenic (As) is no greater than 0.2 ppm, wherein a content of cadmium (Cd) is no greater than 1 ppm, wherein a content of lead (Pb) is no greater than 1 ppm, and wherein a content of mercury (Hg) is no greater than 0.05 ppm as claimed in claim 3. See MPEP 2112.01.I.
Claims 1-3 are rejected under 35 U.S.C. 103 as being unpatentable over US 8568793 B2 to Sherman et al. (Sherman), of record, in view of US 3777007 to Gould et al. (Gould).
Unless otherwise indicated, all disclosed %s without units are interpreted as weight %, and weight % and mass % are interpreted as interchangeable.
Regarding instant claim 1, Sherman at Abstract discloses pharmaceutical grade sodium nitrite and methods of making and methods of treatment using it. Further, at col. 8, lines 35-39, Sherman discloses food grade sodium nitrite as a starting raw material to be purified. The Office considers the claimed “food grade” sodium nitrite to include the pharmaceutical grade sodium nitrite of Sherman because the sodium nitrite of Sherman is at least as pure as a food grade sodium nitrite and is readily used in making food.
Further regarding instant claim 1 and regarding instant claim 3, Sherman at Example 1 and accompanying Table 1 on cols. 33 and 34 discloses a purified sodium nitrite containing 99.2 % by weight (wt%) (as a “content of assay” and a “purity”) of sodium nitrite; a loss on drying of less than 0.01% by weight; an alkalinity content as Na2CO3 (sodium nitrate) of less than 0.05 wt% (no greater than 500 pm); chloride content of less than 0.005 wt% (no greater than 50 ppm); a sulfate content of less than 0.01 wt% (less than 100 ppm), within which disclosed range the claimed no greater than 50 ppm lies; a content of insolubles of 0.001 wt%; a heavy metal content of “NMT 10 ppm”, which the Office considers as meaning that the total amount of heavy metal is at least partly not meaningful but is known to be no greater than about 10 ppm; a mercury content of less than 0.05 ppm as in claim 3; an arsenic content of less than 1 ppm, which includes 0 ppm and within which range all of the claimed no greater than 0.2 ppm of arsenic in claim 3 lies. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art", the Office considers that a prima facie case of obviousness exists. See MPEP 2144.05.I. in addition, the Office considers the purified sodium nitrite of the method of dissolving and purifying a solution of sodium nitrite as in Sherman at col. 3, lines 35-44 to be substantially the same thing as the claimed food grade sodium nitrite. Accordingly, the ordinary skilled artisan in Sherman would have found it obvious to purify its sodium nitrite to reduce the arsenic content to as low a level as possible so as to insure its safety and effectiveness for pharmaceutical use.
Further regarding instant claims 1 and 3, Sherman does not disclose a free-flowing sodium nitrite, does not disclose a content of an anti-caking agent of between 0.25-0.35 % of a food grade sodium nitrite composition, does not disclose a content of a heavy metal cadmium of no greater than 1 ppm of the composition as in claim 1, and does not disclose a content of lead of no greater than 1 ppm of the composition as in claim 3. However, Sherman at col. 14, lines 52-58 discloses powder dosage forms of its sodium nitrite; and, at col. 15, lines 23-27 discloses as diluents sucrose, and powdered sugar, as well as sweeteners. Further, Sherman at col. 9, lines 3-4 discloses a total heavy metal content of no greater than about 10 ppm; and Sherman in Example 1 discloses\the impurities found in its sodium nitrite, including however no listing for lead or cadmium. Accordingly, in regard to lead and cadmium content, claimed content no greater than 1 ppm of lead and of no greater than 1 ppm of heavy metal cadmium content lies within the disclosed range of a total of no greater than 10 ppm of heavy metal in Sherman. See MPEP 2144.05.I. And Sherman at col. 3, lines 35-44 discloses dissolving and purifying sodium nitrite to a pharmaceutical grade. The ordinary skilled artisan in Sherman would have found it obvious to purify its sodium nitrite reduce the lead and cadmium content to as low a level as is possible to insure its safety and effectiveness for pharmaceutical use.
Gould at Abstract discloses mono- and disaccharides in a finely divided state in amounts of from 0.05 to 0.50 weight % as anticaking agents mixed with sodium nitrite or other inorganic salts which are prone to caking. At col. 2, lines 44-45, Gould discloses the free-flowing sodium nitrite compositions as suitable for food and medicinal use.
Before the effective date of the present invention, the ordinary skilled artisan would have found it obvious in view of Gould for Sherman to include the claimed amount of 0.25-0.35 % of anticaking agents in its food grade sodium nitrite to make it free-flowing. Both references disclose powders as sodium nitrite compositions comprising sugars in the form of a dose for medicinal use. The ordinary skilled artisan in Sherman would have desired to use the claimed amount of anticaking agent as a mono- or disaccharide as in Gould to form a pharmaceutically acceptable, suitably sweet and flowable powdered dosage form.
Regarding instant claim 2, the sodium nitrite disclosed in Example 1 at cols. 33-34 of Sherman includes the claimed heavy metal as lead because the claim recites a heavy metals content of less than or about 10 ppm, which includes 0 ppm or no lead. The claimed heavy metal as lead in claim 2 includes the absence of lead as in Sherman at Example 1.
Response to Arguments
In view of the amendment dated September 30, 2025, the following rejections have been withdrawn as moot:
The rejections of claims 1-3 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite in regard to the basis for each of the recited %s in claim 1; in regard to the basis for each of the recited ppm amounts in claims 1 and 3; in regard to each instance of the term “%” without associated units in claim 1; and in regard to each instance of the term “ppm” without associated units in claims 1 and 3.
Regarding the positions taken in the remarks accompanying the amendment dated September 30, 2025 (Reply), the Office has fully considered the positions taken and does not find the positions persuasive for the following reasons
Regarding the positions taken in the Reply and the restriction for lack of unity, the restriction requirement has been made final in the Office action dated July 14, 2025. The position taken in the Reply that the claims are novel and unobvious over the art is found unpersuasive for the reasons detailed below.
In the instant case, where the position taken in the Reply reiterates that one or more properties are not stated in the art; and where there is evidence on the record supporting an obviousness rejection, the rule in stated in In re Best, 562 F.2d 1252, 1255 (CCPA 1977) applies. The rule states: Where the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product. Whether the rejection is based on "inherency" under 35 U.S.C. § 102, on “prima facie obviousness” under 35 U.S.C. § 103, jointly or alternatively, the burden of proof is the same. And as the PTO cannot obtain and compare prior art products, so this burden fairly lies on applicants who are in the best position to meet the burden.
Regarding the positions taken in the Reply at pages 8-9, Juergen at the Description in the paragraph bridging pages 1 and 2 discloses making a free-flowing food grade sodium nitrite by reacting a nitrous acid gas with a sodium hydroxide solution. The Office considers the sodium nitrite made by the stoichiometric reaction of a strong acid gas with sodium hydroxide, a strong base as disclosed in Juergen to produce a virtually 100% pure composition of sodium nitrite and water. Further, additional evidence from the instant specification at page 2, lines 16-21 discloses that impure sodium nitrite is formed from pollutants as a result of poor industrial hygiene in developing countries. The Reply nowhere address the significance of avoiding poor industrial hygiene and making a sodium nitrite that is pure. Nothing in Juergen suggests any such problem. In fact, the strong acid gas and strong base reactants disclosed in Juergen suggest high purity. In summary, the Office action tasked Applicants to make a showing that the Juergen sodium nitrite did not meet the claimed purity parameters. The reply does not contain any such showing and the evidence supports the findings that the claimed purity parameters are at least obvious over Juergen.
Regarding the positions taken in the Reply at page 9 that there is no disclosure or motivation in Juergen to achieve all of the claimed parameters concurrently, the Office respectfully disagrees because all of the claimed impurities are harmful if found in food or impair the free-flowing nature of sodium nitrite.
Regarding the positions taken in the Reply at pages 9-10 alleging that Sherman fails to disclose or suggest the specific compositional limitations and the stringent impurity profile recited in the presently amended claims, respectfully the Office considers the sodium nitrite made by Sherman at Abstract as a pharmaceutical grade sodium nitrite and disclosed at col. 8, lines 35-39, Sherman as starting from a food grade sodium nitrite as a starting raw material to be more pure than a food grade sodium nitrite. On top of this evidence, Sherman at col. 9, lines 3-4 discloses a total heavy metal content of no greater than about 10 ppm. The Reply nowhere address the purity of a pharmaceutical grade sodium nitrite, or the standards required for such a thing. In summary, the Office action tasked Applicants to make a showing that the Sherman sodium nitrite did not meet the claimed purity parameters. The reply does not contain any such showing and the evidence supports the findings that the claimed purity parameters are at least obvious over Sherman.
Regarding the positions taken in the Reply at pages 10-11 alleging that Sherman does not disclose the claimed anticaking agent of 0.25-0.35 wt.%, respectfully this position is not found persuasive because the rejection relies on Gould for the showing of such amounts in medical grade sodium nitrite. Further, Sherman at col. 15, lines 23-27 discloses as diluents sucrose and powdered sugar, as well as sweeteners which are the same as the anticaking agents of Gould, that are used in the same way in a powdered sodium nitrite in Sherman and Gould or salt to make the same free-flowing food grade material as in Gould.
Regarding the positions taken in the Reply at page 11 alleging that Sherman essentially comprises of components such as water, ethanol, methanol, non-volatile organic carbon, selenium and bacterial endotoxins which are nowhere required or present in the Applicant's pending claim 1, respectfully the claims are open-ended and do not exclude anything not specifically recited in the claims as lacking or otherwise limited. Also, Sherman at Example 1 and accompanying Table 1 on cols. 33 and 34 discloses a loss on drying of less than 0.01% by weight and thereby meets the claims with respect to the amount of water and the amount of any volatiles.
Regarding the positions taken in the Reply at pages 10-11 that Gould discloses a broad anticaking agent range (0.05-0.50 wt.%) but does not teach or suggest narrowing it to 0.25-0.35 wt.% in combination with the rigorous impurity profile of the present claims, respectfully the ordinary skilled artisan would desire to use any amount of anticaking agent disclosed in Gould because Gould says that such amounts are desirable for making a free-flowing sodium nitrite or salt. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art", the Office considers that a prima facie case of obviousness exists. See MPEP 2144.05.I.
Regarding the positions taken in the Reply at pages 11-13 providing results of an assay of the disclosed sodium nitrite, the showing offered does not address the cited art in any way. Rather, the position merely repeats positions already addressed and is taken as a general allegation of patentability. See 37 CFR 1.111(b).
Conclusion
THIS ACTION IS MADE FINAL. 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 ANDREW E MERRIAM whose telephone number is (571)272-0082. The examiner can normally be reached M-H 8:00A-5:30P and alternate Fridays 8:30A-5P.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Nikki H Dees can be reached at (571) 270-3435. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.E.M./Examiner, Art Unit 1791 /Nikki H. Dees/Supervisory Patent Examiner, Art Unit 1791
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