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 .
Claim Status
Applicant’s election without traverse of Group I and the species of: a)sodium nitrite nitric oxide releasing compound, b) citric acid acidifying agent, c) liquid solution form, d) treatment of warts, and e)topical administration in the reply filed on 06/17/2025 is acknowledged. Claims 6-39, 48, and 58-63 are withdrawn. withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06/17/2025.
Claims 1-5 and 38-41 are under current examination.
Objection to the Title
The following title is suggested: It is believed that Applicants meant to recite “nitric oxide” and not “ntiric oxide” for the title.
Claim Objections
Claim 1 recites “an administration situs of the subject”. For readability of the claim, it is suggested that “situs” can be replaced with the word “site”.
Claim Rejections - 35 USC § 112(b) Indefinite
Claims 1-5 and 38-41 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites: wherein when measured by releasing NO from the NORS for a period of 30 minutes into a flow of substantially inert carrier gas at a flow rate of 1 liter per minute and a pressure of 1 atmosphere, coupled to a chemiluminescence detector, said NORS releases NO in an amount of from about 1 ppm*min/mL to about 500 ppm*min/mL based on 1 mL of the NORS”. Claim 38 recites that the NO releases 10ppm*min/mL to about 60 ppm*min/mL based on 1mL of the NORS. Claim 3 recites a volume of from 0.1-10,000mL and claim 40 recites a volume from 0.5-10mL of the NORS. It is unclear what the intended volume and release amount of the NO from NORS is meant to encompass. It is unclear if the NORS in claim 1 constitutes a volume of 1mL and NO is released from 1ppm*min-500ppm*/min or if the volume of NORS is meant to be from 0.1-10,000mL and the NO is from 6-75,000ppm*min. The “when measured” renders the claim indefinite because it is unclear if the volume of NORS is and the amount of NO released is meant to be required by the claim or not. For the purpose of examination of the claims, the total volume of claim 1 for the NORS is interpreted as when present 1mL with the release of NO being interpreted as 1ppm*min to 500ppm*min for a total volume of 1mL.
The term “substantially inert ” in claim 1 is a relative term which renders the claim indefinite. The term “substantially inert” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear if the carrier gas is inert or to what degree the gas is inert to be considered substantially inert.
Claim Rejections - 35 USC § 112(d) failure to further limit
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.
Claims 3-4 and 39-41 are 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.
Claim 3 recites wherein the volume of NORS if from about 0.1-10,000mL. However the volume of NORS of claim 1 is 1mL which releases NO in an amount of from 1-500ppm*min/mL. The volume of about 0.1-10,000mL appears to broaden the volume of the NORS of claim 1.
Claim 4 recites that the NO released by the volume of NORS administered is from 6-75,000ppm*min. However, the release of claim 1 based on a total volume of 1mL is from 1-500ppm. Thus the ppm of claim 4 appears to broaden the amount of claim 1.
Claim 39 recites that the total amount of NO released by the volume of NORS is from about 20-400ppm*min. However, the release of claim 38 is from 10-60ppm*min. Thus, the ppm of claim 39 appears to broaden the amount required by claim 38.
Claim 40 recite that the volume of NORS is administered from about 0.5-10mL. However, claim 1 and claim 38 suggests that the NORS is a 1mL concentration. The amount of NORS of claim 40 appears to broaden 1mL volume of claim 1 and 38.
Claim 41 recites that the volume of NORS releases a peak NO concentration of about 1-60ppm. The peak concentration appears to be broader than the amount of from 10-60ppm earlier recited in claim 38.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 3 and 5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Miller et al. (WO2016027163).
Miller et al. teach administering nitric oxide to a subject’s mammary tissue from a nitric oxide releasing solution, see claim 1. The nitric oxide releasing solution is used to treat warts, see claims 1 and 14. The NORS can comprise a nitrite salt and acidifying agent, see claim 4. Example 2 teaches the antibacterial effect of NORS solution on a skin surface which contains sodium nitrate and citric acid as the preferred nitrite salt and citric acid as the preferred acidifying agent. The amount combined to form an activated solution is 10-50mL, page 13, lines 17-33 and claim 14 and claims 7, 37, and 78-79.
Regarding the limitation “when measured by releasing NO from the NORS for a period of 30 minutes into a flow of substantially inert carrier gas at a rate of 1 liter per minute and pressure of 1atm, coupled to a chemiluminescence detector, said NORS releases NO in an amount of from 1ppm*min to about 50 ppm*min per mL based on 1mL of the NORS, this limitation characterizes measurement of the solution after 30 minutes but the claim does not require measurement in view of “when measured”. Since Miller et al. teaches the exact same composition as claimed having NORS in an anticipatory amount with acidifying agent (citric acid) and nitrite salt (sodium nitrite), Miller anticipates the claimed invention.
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 1-5 and 38-41 are rejected under 35 U.S.C. 103 as being unpatentable over Miller et al. (WO2016027163).
Miller et al. teach administering nitric oxide to a subject’s mammary tissue from a nitric oxide releasing solution, see claims 1-14 and entire document. The nitric oxide releasing solution can be liquid and is used to treat warts, see claims 1, 4-5 and 14 and page 31, line 33. The NORS can comprise a nitrite salt and acidifying agent, see claim 4. The nitrate salt can comprise sodium nitrate, see page 10, lines 23-33. Example 2 teaches the antibacterial effect of NORS solution on a skin surface which contains sodium nitrate and citric acid as the preferred nitrite salt and citric acid as the preferred acidifying agent.. In one example, Miller teaches treating a mammary condition in a subject is described, which comprises a first component configured to release gNO upon acidification thereof; a second component configured to acidify the first component; and a device for administering the first and second component such that when combined, the components form a composition that releases a therapeutically effective amount of gNO to the subject, see paged 31, lines 13-20, 32, lines 20-30, page 33, lines 9-10, page 35, lines 15-20 and claims 28-47. The acidifying agent and nitrile salt are combined to form an activated composition in amounts from 10-50mL, see pages 31, lines 13-20 and entire document. The NORS can also be administered from 0.25-50mL, see page 31, lines 19-20. The NORS can release a therapeutically amount of gNO which includes from 4-10,000ppm, see page 12, lines 17-33. In one embodiment the concentration can be from 100-500ppm and in another 50-200ppm, see page 13, lines 17-33. The NORS can be configured to release between 1 minute an 24 hours, see page 19, lines 10-12. Since the NORS can comprise 4-10,000ppm and can be administered from 10-50mL, this inclusive of a range of 200-1000ppm/mL (when 10,000ppm administered at a concentration from 10-50mL). Since the NORS is taught to be administered from 1 min to 24 hours this is inclusive of from 200-1000ppm*min per mL. When utilizing 100ppm which overlaps the range of 4-10,000ppm taught by Miller at a concentration of 10-50mL, the concentration per min is from 2-10ppm/mL (for 50mL). 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).
Miller teaches the claimed invention having overlapping ranges for releasing NO (ppm) and the volume of NORS (mL). In view of the teachings of Miller it would have been prima facie obvious to treat warts with a nitric oxide releasing solution that comprises citric acid and sodium nitrite and to provide the NORS in an amount from 10-50mL an amount of NO from 4-10,000ppm for a time period inclusive of from 1 minute to 24 hours as suggested by miller. . Per MPEP 2144.05, 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).
According to the instant invention, the acidifying agent can be present from 0.1-4w/v with the (paragraph [0067] with the sodium nitrate present from 0.1-1.5w/v. (paragraph 0065). Miller teaches overlapping amounts as acidifying agent such as citric acid can be present from 0.07-10% w/v, with a mounts of sodium nitrate from 0.07-2 w/v, see page 13, lines 18-20 and page 11, lines 1-35. Since Miller renders obvious the instantly claimed invention and utilizes a NORS solution in overlapping amounts with overlapping amounts of acidifying agent and sodium nitrate, the property of “when measured by releasing NO from the NORS for a period of 30 minutes into a flow of substantially inert carrier gas at a rate of 1 liter per minute and pressure of 1atm, coupled to a chemiluminescence detector, said NORS releases NO in an amount of from 1ppm*min to about 50 ppm*min per mL based on 1mL of the NORS would necessarily follow. It is further noted that this limitation recites “when measured” characterizes measurement of the solution after 30 minutes but does not appear to require the measurement. Since Miller et al. teaches the same composition as claimed having the same volume of NORS with overlapping amounts of citric acid and sodium nitrite, Miller renders obvious the claimed release of NO based on 1mL of NORS.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-5 and 38-41 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 15-16, and 21 of copending Application No. 18207099 (reference application) in view of Miller et al. (WO2016027163).
Claims 1-5 and 38-41 are directed to an invention not patentably distinct from claims 15-16, and 21 commonly assigned 18207099.
The U.S. Patent and Trademark Office may not institute a derivation proceeding in the absence of a timely filed petition. The USPTO normally will not institute a derivation proceeding between applications or a patent and an application having common ownership (see 37 CFR 42.411). Commonly assigned 18207099, discussed above, may form the basis for a rejection of the noted claims under 35 U.S.C. 102 or 103 if the commonly assigned case qualifies as prior art under 35 U.S.C. 102(a)(2) and the patentably indistinct inventions were not commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention.
In order for the examiner to resolve this issue the applicant or patent owner can provide a statement under 35 U.S.C. 102(b)(2)(C) and 37 CFR 1.104(c)(4)(i) to the effect that the subject matter and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person. Alternatively, the applicant or patent owner can provide a statement under 35 U.S.C. 102(c) and 37 CFR 1.104(c)(4)(ii) to the effect that the subject matter was developed and the claimed invention was made by or on behalf of one or more parties to a joint research agreement that was in effect on or before the effective filing date of the claimed invention, and the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; the application must also be amended to disclose the names of the parties to the joint research agreement.
A showing that the inventions were commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention will preclude a rejection under 35 U.S.C. 102 or 103 based upon the commonly assigned case. Alternatively, applicant may take action to amend or cancel claims such that the applications, or the patent and the application, no longer contain claims directed to patentably indistinct inventions.
Both the instant claims and that of Application ‘099 deliver NORS, an acidifying agent and a nitric oxide releasing compound to treat skin. The claims of ‘099 do not teach the presence of sodium nitrite with citric acid as the acidifying agent in amounts that include 1mL NORS in solution and from 1-500ppm per min per mL.
However, Miller et al. teach administering gashouse nitric oxide to a subject’s mammary tissue from a nitric oxide releasing solution, see claim 1. The nitric oxide releasing solution is used to treat warts, see claims 1 and 14. The NORS can comprise a nitrite salt and acidifying agent, see claim 4. Example 2 teaches the antibacterial effect of NORS solution on a skin surface which contains sodium nitrate and citric acid as the preferred nitrite salt and citric acid as the preferred acidifying agent.. In one example, a system for treating a mammary condition in a subject, as recited in any of the previous examples, is described, which comprises a first component configured to release gNO upon acidification thereof; a second component configured to acidify the first component; and a device for administering the first and second component such that when combined, the components form a composition that releases a therapeutically effective amount of gNO to the subject. The acidifying agent and nitrile salt are combined to form an activated composition in amounts from 10-50mL. The NORS can also be administered from 0.25-50mL. The NORS can release a therapeutically amount of gNO which includes from 4-10,000ppm. In one embodiment the concentration can be from 100-500ppm and in another 50-200ppm. The NORS can be configured to release between 1 minute an 24 hours. Since the NORS can comprise 4-10,000ppm and can be administered from 10-50mL, this inclusive of a range of 200-1000ppm/mL (when 10,000ppm administered at a concentration from 10-50mL). Since the NORS is taught to be administered from 1 min to 24 hours this is inclusive of from 200-1000ppm per min per mL. When utilizing 100ppm which overlaps the range of 4-10,000ppm taught by Miller at a concentration of 10-50mL, the concentration per min is from 2-50ppm/mL. 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). The nitrate salt which includes sodium nitrate can be present from 0.07-2w/v with acidifying agent taught to be from 0.07-10% w/v. The addition of the acidifying agent including citric acid helps increase production of NO. The nitric oxide releasing compound includes sodium nitrite.
It would have been obvious to provide the nitric oxide composition of Application ‘099 as a NORS that comprises citric acid and sodium nitrite as the nitric oxide releasing compound in the method of treating warts in an amount that includes 1mL as suggested by Miller and from 4-10,000ppm of NORS administered from 10-50mL (inclusive of 200-1000ppm per min per mL or from 2-50ppm per min per ML).
One of ordinary skill in the art would have been motivated to do so because Miller teaches that the NORS composition having acidifying agent and nitrite salt including sodium nitrate are useful in treating viral infections such as warts and the composition of Application ‘485 treats a skin surface.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-5 and 38-41 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of copending Application No. 19/031,893 (reference application).
Claims 1-5 and 38-41 are directed to an invention not patentably distinct from claims 1-4 commonly assigned 19/031,893.
The U.S. Patent and Trademark Office may not institute a derivation proceeding in the absence of a timely filed petition. The USPTO normally will not institute a derivation proceeding between applications or a patent and an application having common ownership (see 37 CFR 42.411). Commonly assigned 19/031,893, discussed above, may form the basis for a rejection of the noted claims under 35 U.S.C. 102 or 103 if the commonly assigned case qualifies as prior art under 35 U.S.C. 102(a)(2) and the patentably indistinct inventions were not commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention.
In order for the examiner to resolve this issue the applicant or patent owner can provide a statement under 35 U.S.C. 102(b)(2)(C) and 37 CFR 1.104(c)(4)(i) to the effect that the subject matter and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person. Alternatively, the applicant or patent owner can provide a statement under 35 U.S.C. 102(c) and 37 CFR 1.104(c)(4)(ii) to the effect that the subject matter was developed and the claimed invention was made by or on behalf of one or more parties to a joint research agreement that was in effect on or before the effective filing date of the claimed invention, and the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; the application must also be amended to disclose the names of the parties to the joint research agreement.
A showing that the inventions were commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention will preclude a rejection under 35 U.S.C. 102 or 103 based upon the commonly assigned case. Alternatively, applicant may take action to amend or cancel claims such that the applications, or the patent and the application, no longer contain claims directed to patentably indistinct inventions.
Both the instant claims and that of Application ‘893 teach delivery of nitric oxide releasing agent, acidifier that releases NO. The conditions being treated include viruses. The claims of ‘893 do not teach the presence of sodium nitrite with citric acid as the acidifying agent in amounts that include 1mL NORS in solution and from 1-500ppm per min per mL.
However, Miller et al. teach administering gashouse nitric oxide to a subject’s mammary tissue from a nitric oxide releasing solution, see claim 1. The nitric oxide releasing solution is used to treat warts, see claims 1 and 14. The NORS can comprise a nitrite salt and acidifying agent, see claim 4. Example 2 teaches the antibacterial effect of NORS solution on a skin surface which contains sodium nitrate and citric acid as the preferred nitrite salt and citric acid as the preferred acidifying agent.. In one example, a system for treating a mammary condition in a subject, as recited in any of the previous examples, is described, which comprises a first component configured to release gNO upon acidification thereof; a second component configured to acidify the first component; and a device for administering the first and second component such that when combined, the components form a composition that releases a therapeutically effective amount of gNO to the subject. The acidifying agent and nitrile salt are combined to form an activated composition in amounts from 10-50mL. The NORS can also be administered from 0.25-50mL. The NORS can release a therapeutically amount of gNO which includes from 4-10,000ppm. In one embodiment the concentration can be from 100-500ppm and in another 50-200ppm. The NORS can be configured to release between 1 minute an 24 hours. Since the NORS can comprise 4-10,000ppm and can be administered from 10-50mL, this inclusive of a range of 200-1000ppm/mL (when 10,000ppm administered at a concentration from 10-50mL). Since the NORS is taught to be administered from 1 min to 24 hours this is inclusive of from 200-1000ppm per min per mL. When utilizing 100ppm which overlaps the range of 4-10,000ppm taught by Miller at a concentration of 10-50mL, the concentration per min is from 2-50ppm/mL. 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). The nitrate salt which includes sodium nitrate can be present from 0.07-2w/v with acidifying agent taught to be from 0.07-10% w/v. The addition of the acidifying agent including citric acid helps increase production of NO. The nitric oxide releasing compound includes sodium nitrite.
It would have been obvious to provide the nitric oxide composition of Application ‘893 as a NORS that comprises citric acid and sodium nitrite as the nitric oxide releasing compound in the method of treating warts in an amount that includes 1mL as suggested by Miller and from 4-10,000ppm of NORS administered from 10-50mL (inclusive of 200-1000ppm per min per mL or from 2-50ppm per min per ML).
One of ordinary skill in the art would have been motivated to do so because Miller teaches that the NORS composition having acidifying agent and nitrite salt including sodium nitrate are useful in treating viral infections such as warts and the composition of Application ‘893 treats viruses.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Currently, no claims are allowed and all claims are rejected.
Correspondence
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/SARAH ALAWADI/Primary Examiner, Art Unit 1619