DETAILED ACTION
Claims 11-18 are currently pending and under examination.
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 .
Specification
The amendments submitted 05/04/2026 will be entered.
Withdrawn Rejections
The prior rejection of claims 11-14 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph is withdrawn in light of Applicant’s amendment to remove the limitation of preventing, which the Examiner finds persuasive.
The prior rejection of claim(s) 11-12 and 15-16 under 35 U.S.C. 103 as being unpatentable over EP 1 435 924 is withdrawn as a result of Applicant amendment instant claims 11 and 15 to remove the agent being nitric oxide, which the ‘924 publication does not teach.
Examiner’s Note
Applicant's amendments and arguments filed 05/04/2026 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. In the Applicant’s response, filed 05/04/2026, it is noted that claims 11, 13-15 and 17 have been amended and no new matter or claims have been added.
New Rejection:
The following rejections are newly added based on Applicant’s claim amendments.
Claim Rejections - 35 USC § 112 (b)
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 11-18 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.
Claims 11 and 15 contain the limitation “nitric oxide generating composition comprises each independently one or more nitrite salt, a portion source comprising one or more acid… and one or more organic polyol”. The limitation of “each independently” is unclear as to whether only of nitrite salt, proton source and organic polyol are required, one ingredient from each group, or how “each independently” limits the scope of the claim, thus providing unclear metes and bounds of the instant claim. Claims 12-14 and 16-18 are further rejected as not clarifying the ambiguity of claims 11 and 15.
Claims 12 and 16 recite the limitation "the agent" in first line. There is insufficient antecedent basis for this limitation in the claim. Claims 11 and 15 recite the limitation of “one or more agent”, wherein “the agent” does not properly refer back to “one or more agent”.
Modified Rejections:
The following rejections are modified based on Applicant’s claim amendment.
Claim Rejections - 35 USC § 112 (b)
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 11-18 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.
Claims 11 and 15 contains the limitation of “one or more agent selected from nitric oxide generating composition, a combination or combinable association of ingredients for nitric oxide generating composition and mixtures there” and additionally “wherein the nitric oxide generating compristion or the combination or combinable association of ingredients for nitric oxide generating compristion comprises….”. It appears that the “nitric oxide generating composition” “or the combination or combinable association of ingredients for nitric oxide generating composition” is defined as the same ingredients by claim 11 and 15. Thus the use of multiple recitations make the claim unclear as to whether the scope is different for the composition or the combination or combinable association of ingredients, thus making the instant claim have unclear metes and bounds. Claims 12-14 and 16-18 are further rejected as not clarifying the ambiguity of claims 11 and 15
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.
Claim(s) 11-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2009/0196930 (previously provided) in view of EP 1 435 924 (Applicant provided).
Regarding claims 11-18, the limitation of a method of treating tuberculosis or an infection arising from the bacterium M. tuberculosis in a human or animal subject comprising administering to the human or animal subject an antibacterially effective amount of one or more agent selected from nitric oxide generating compristion or mixture thereof is met by the ‘930 publication teaching nitrite, nitrite salt or nitric oxide producing compounds suitable for aerosolization and use of such formulations for aerosol administration for treatment of pulmonary bacterial infections (abstract). The nitrite compound formulation for pulmonary delivery comprises an aqueous solution comprising sodium nitrite, citric acid [0045] wherein the liquid formulation includes the carrier such as water and glycerol to form a solution or suspension to be aerosolized can be prepared in conventional forms [0226] or excipient like mannitol [0224]. The bacteria may be gram-negative bacteria includes mycobacterium tuberculosis [0138]. The ’930 publication teaches upon admixture of nitrite compound and an acidic excipient to form the compristion [0038] wherein the composition may be subsequently diluted [0226], thus teaching the composition may be formed at the desired concentration or may need to be further diluted. Treatment of a human is taught [0110]. The ‘930 publication teaches methods of treating bacterial infection comprise administer nebulized nitrite to a subject infected, predisposed to or suspected of having an infection by a pathogenic bacterial in the lungs [0131] wherein an antimicrobial effect is taught [00134] and reduction of bacterial population is taught [0136].
The ’930 publication does not teach the specific combination of nitric oxide precursors for reduction in the amount of viable M. tuberculosis bacteria on the surface or in the space.
The ‘924 publication teaching nitric oxide for use in therapy using nitric oxide and nitric oxide precursors ([0001]-[0002]). NO is dispersed and/or dissolved in solution [0015]. Liquid formulations of nitric oxide may be administered by nebulizer for treatment of tuberculosis [0019], which reads on treating a surface which is part of a human or animal body. The liquid mixture may be made by the combination of nitrite with an organic acid such as ascorbic acid [0023] to treat tuberculosis [0037] and treatment of Mycobacterium tuberculosis [0035].
It would have been prima facie to one of ordinary skill in the art before the filing date of the claimed invention to use sodium nitrite, citric acid and mannitol to treat tuberculosis or reduce the amount of viable M. tuberculosis bacteria on the surface as the ‘930 publication teaches the composition which comprises sodium nitrite, citric acid and mannitol and may be administered to a human to treat bacteria such as Mycobacterium tuberculosis and the ‘924 publication specifically teaches nitric oxide sources to be administered by nebulizer to treat respiratory diseases such as Mycobacterium tuberculosis [0019]. One of ordinary skill in the art before the filing date of the claimed invention would be motivated to use sodium nitrite to reduce M. tuberculosis as the ‘924 publication and the ’930 publication both teach the use of nitric oxide generators in the treatment of M. tuberculosis and the ‘930 publication teaches methods of treating bacterial infection comprise administer nebulized nitrite to a subject infected, predisposed to or suspected of having an infection by a pathogenic bacterial in the lungs [0131] wherein an antimicrobial effect is taught [00134] and reduction of bacterial population is taught [0136], thus rendering it obvious to use inhaled sodium nitrite to reduce M. tuberculosis in the body surface such as the lung and the ‘924 publication provides the specific connection between nitric oxide generators and treatment of M. tuberculosis and tuberculosis.
Consistent with this reasoning, it would have been obvious to have selected various combinations of disclosed ingredients (sodium nitrite, citric acid and mannitol composition for treatment of tuberculosis and reduction in viable M. tuberculosis bacteria) from within the prior art disclosure of the ‘924 publication and the ‘924 publication, to arrive at the instantly claimed treating a surface in the body to reduce M. tuberculosis bacteria or treat tuberculosis “yielding no more than one would have expected from such an arrangement”.
Response to Arguments:
Applicant’s arguments have been fully considered and are not deemed to be persuasive.
112:
Applicant argues the 112(b) rejection should be withdrawn as the claims are amended to enhance clarity.
In response, the limitation of “a nitric oxide generating composition, a combination or combinable association of ingredient for a nitric oxide generating comprising and mixture thereof” is still present and defined by the same ingredients, thus the instant claims do not clarify the distinction between “nitric oxide generating compristion” and “a combination or a combinable association of ingredient for a nitrox oxide generating composition”. Thus the 112(b) rejection is modified and maintained based on Applicant’s claim amendment.
103: the ‘930 publication (Suber) in view of the ‘924 publication (Tucker)
Applicant argues there is not motivation to select one or more polyols. The ‘930 publication teaches nitrite compound formation comprising sodium nitrite and citric acid and further describes formation can be administered in combination with conventional pharmaceutical carrier excipient and the like and list of examples include mannitol, lactose, starch magnesium stearate….”. A PHOSITA would have understood that conventional pharmaceutical carriers, inactive ingredient, generally do not affect the efficacy of the compristion and thus would have not motivation to select any particular pharmaceutically conventional carrier or excipient to improve generation of nitric oxide and enhance efficacy of the active ingredient agent microbes.
In response, the ‘930 publication specifically teaches additional ingredient to include mannitol selected from a short list of specifically recited convention carriers to be used, thus providing motivation and expectation of success in using the mannitol in the formation taught by the ‘930 publication as the ‘930 publication specifically teaches sodium nitrite administered with convention carrier which include mannitol and citric acid [0224]. “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious”. KSR v. Teleflex, 127 S,Ct. 1727, 1740 (2007)(quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976)). The ‘930 publication teaches nitrite, nitrite salt or nitric oxide producing compounds suitable for aerosolization and use of such formulations for aerosol administration for treatment of pulmonary bacterial infections (abstract), thus teaching efficacy of the active ingredient against microbes.
Applicant argues not reasonable expectation of success. The present specification describes that organic polyols affect the generation of nitric oxide ([0547]-[0548]), Figure 1 shows an increase in the cumulative output of nitric oxide in the presence of mannitol and sorbitol compared to no polyol. Examples 3-9 demonstrate that the presence of polyol increases the efficacy against microbial colonies thereby demonstrating enhanced anti-microbial activity. The ‘930 publication merely describes mannitol and glycerol as pharmaceutically convention excipients and carriers with no particular teaching or suggestion towards selected polyols as the excipient or carrier let alone an increase in nitric oxide efficacy.
In response, Applicant has presented unexpected results that are not commensurate in scope with the instant claims. Applicant presents data regarding specific compositions including mannitol, citric acid and sodium nitrite. The claims are more broadly directed to composition comprising each independently one or more nitrite salt, proton source comprising one or more acid selected from organic carboxylic acid and organic non-carboxylic reducing acids and one or more organic polyols, which is much broader than the tested embodiments. Applicant points to Figure 1, wherein 3 is additionally provided and demonstrate the specific polyol selected has a strong effect on the final compositions, wherein polyols tested do not appear to be superior to none present as shown in figure 3. Additionally Figure 7 and 10 further demonstrates the proton source selected has a strong effect on the final composition, wherein citric acid and ascorbic were tested. Applicant has not presented evidence for the full scope of the instant claims nor provided a nexus between unexpected superior results and the instant claims, treating or alleviating tuberculosis or an infection arising from the bacterium M. tuberculosis.
Conclusion
No claims are 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.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNDSEY MARIE BECKHARDT whose telephone number is (571)270-7676. The examiner can normally be reached Monday-Thursday 9am to 4pm and Friday 9am to 2pm.
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/LYNDSEY M BECKHARDT/Examiner, Art Unit 1613
/BRIAN-YONG S KWON/Supervisory Patent Examiner, Art Unit 1613
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