DETAILED ACTION
Notice of Pre-AIA or AIA Status
The inventor or joint inventor should note that the instant invention, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
Claims 1, 2, 7, 8, 12-14, 19, 20 and 24-26 are pending in the instant invention. According to the Amendments to the Claims, filed July 28, 2026, claims 1, 2, 7, 8, 12-14, 19, 20 and 24 were amended, claims 3-6, 9-11, 15-18 and 21-23 were cancelled and claims 25 and 26 were added.
Status of Priority
This invention is a Continuation (CON) of abandoned US Application No. 18/128,021, filed March 29, 2023, which is a Continuation (CON) of abandoned US Application No. 17/217,187, filed March 30, 2021, which is a Continuation (CON) of abandoned US Application No. 16/576,931, filed September 20, 2018, claims priority under 35 U.S.C. § 119(e) to US Provisional Application No. 62/734,097, filed September 20, 2018.
Status of Restrictions / Election of Species
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The forthcoming second Office action and prosecution on the merits includes (1) claims 1, 2, 7 and 25, drawn to a method for treating a metabolic condition in a subject, wherein the method comprises administering… 5-(2-nitroethenyl)salicylic acid (SANA) of the Formula I, shown to the right above; (2) claims 8 and 12, drawn to a method for elevating body temperature in a subject, wherein the method comprises administering… 5-(2-nitroethenyl)salicylic acid (SANA) of the Formula I, shown to the right above; (3) claims 13, 14, 19 and 26, drawn to a method for treating a metabolic condition in a subject, wherein the method comprises administering… a pharmaceutical composition comprising… 5-(2-nitroethenyl)-salicylic acid (SANA) of the Formula I, shown to the right above; and (4) claims 20 and 24, drawn to a method for elevating body temperature in a subject, wherein the method comprises administering… a pharmaceutical composition comprising… 5-(2-nitroethenyl)salicylic acid (SANA) of the Formula I, shown to the right above, respectively.
Similarly, the inventor or joint inventor should further note that the sections of U.S.C. Title 35 that formed the basis of prior rejections formulated, as well as any references supporting said rejections, that are not included with this Office action, may be found in the Non-Final Rejection, mailed on April 29, 2026.
Moreover, the inventor or joint inventor should further note that any rejections and/or objections of record not explicitly addressed herein below, are hereby withdrawn, in light of the inventor’s or joint inventor’s arguments and/or the Amendments to the Claims, filed July 28, 2026.
Thus, a second Office action and prosecution on the merits of claims 1, 2, 7, 8, 12-14, 19, 20 and 24-26 is contained within.
New Specification Objection - Title
The inventor or joint inventor is reminded of the proper content of the title of the invention.
The title of the invention should be brief, but technically accurate and descriptive and should contain fewer than 500 characters. See 37 CFR 1.72(a) and MPEP § 606.
The title of the invention is not technically accurate and descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed. In the revised title, the examiner suggests identifying: a) 5-(2-nitroethenyl)salicylic acid (SANA) of the Formula I; and b) a particular utility for 5-(2-nitroethenyl)salicylic acid (SANA) of the Formula I.
The following title is suggested: (E)-5-(2-NITROETHENYL)SALICYLIC ACID (SANA) FOR TREATING METABOLIC CONDITIONS.
Appropriate correction is required.
New Claim Objections
Claim 1 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
A method for treating a metabolic condition in a subject in need thereof, wherein the method comprises administering to the subject a therapeutically effective amount of a compound of Formula I:
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I
or a pharmaceutically acceptable salt thereof;
wherein the metabolic condition is selected from the group consisting of metabolic syndrome and type II diabetes.
Appropriate correction is required. See MPEP § 2173.02.
Claim 7 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
The method of claim 1, wherein the method further comprises administering to the subject a therapeutically effective amount of an additional therapeutic agent.
Appropriate correction is required. See MPEP § 2173.02.
Claim 8 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
A method for elevating body temperature in a subject in need thereof, wherein the method comprises administering to the subject a therapeutically effective amount of a compound of Formula I:
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or a pharmaceutically acceptable salt thereof.
Appropriate correction is required. See MPEP § 2173.02.
Claim 12 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
The method of claim 8, wherein the method further comprises administering to the subject a therapeutically effective amount of an additional therapeutic agent.
Appropriate correction is required. See MPEP § 2173.02.
Claim 13 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
A method for treating a metabolic condition in a subject in need thereof, wherein the method comprises administering to the subject a therapeutically effective amount of a pharmaceutical composition comprising a pharmaceutically acceptable carrier and a compound of Formula I:
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or a pharmaceutically acceptable salt thereof;
wherein the metabolic condition is selected from the group consisting of metabolic syndrome and type II diabetes.
Appropriate correction is required. See MPEP § 2173.02.
Claim 19 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
The method of claim 13, wherein the method further comprises administering to the subject a therapeutically effective amount of an additional therapeutic agent.
Appropriate correction is required. See MPEP § 2173.02.
Claim 20 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
A method for elevating body temperature in a subject in need thereof, wherein the method comprises administering to the subject a therapeutically effective amount of a pharmaceutical composition comprising a pharmaceutically acceptable carrier and a compound of Formula I:
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or a pharmaceutically acceptable salt thereof.
Appropriate correction is required. See MPEP § 2173.02.
Claim 24 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
The method of claim 20, wherein the method further comprises administering to the subject a therapeutically effective amount of an additional therapeutic agent.
Appropriate correction is required. See MPEP § 2173.02.
Claim 25 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
The method of claim 1, wherein the metabolic condition is metabolic syndrome.
Appropriate correction is required. See MPEP § 2173.02.
Claim 26 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
The method of claim 13, wherein the metabolic condition is metabolic syndrome.
Appropriate correction is required. See MPEP § 2173.02.
New Claim Rejections - Obviousness-type 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 obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined invention claim is not patentably distinct from the reference claims because the examined invention claim is either anticipated by, or would have been obvious over, the reference claims. {See 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); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969)}.
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Consequently, at least claims 1, 2, 7, 13, 14 and 19 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-16 of US Patent No. 11,400,066. Although the conflicting claims are not identical, they are not patentably distinct from each other because claim 1 in US 11,400,066 recites a method of treating a subject in need thereof,… wherein the subject in need thereof suffers from a condition selected from the group consisting of… type II diabetes… comprising administering… 5-(2-nitroethenyl)salicylic acid (SANA) of the Formula I, shown to the right, which provides overlapping subject matter with respect to the instantly recited method of treating a metabolic condition in a subject, comprising administering… 5-(2-nitroethenyl)salicylic acid (SANA) of the Formula I, shown to the right above.
The inventor or joint inventor should note that [T]he discovery of a previously unappreciated property of a prior art compound, or of a scientific explanation for the prior art’s functioning, does not render the old compound patentably new to the discoverer. {See Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999)}.
Similarly, the inventor or joint inventor should further note that [T]he claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. {See In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977); and In re Crish, 393 F.3d 1253, 1258, 73 USPQ2d 1364, 1368 (Fed. Cir. 2004)}.
Likewise, the inventor or joint inventor should note that [W]hen the claim recites using an old compound and the use is directed to a result or property of that compound, then the claim is anticipated. {See In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978); and In re Tomlinson, 363 F.2d 928, 150 USPQ 623 (CCPA 1966)}.
Next, the inventor or joint inventor should further note that [P]roducts of identical chemical composition may not have mutually exclusive properties. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties the inventor or joint inventor discloses and/or claims are necessarily present. {See In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990)}.
Then, the inventor or joint inventor should further note that a timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 37 CFR 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground, provided the conflicting invention or patent either is shown to be commonly owned with this invention, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Moreover, the inventor or joint inventor should further note that the USPTO internet Web site contains terminal disclaimer forms which may be used, and the inventor or joint inventor is encouraged to visit http://www.uspto.gov/forms/, where (i) the filing date of the invention will determine what form should be used, and (ii) a web-based eTerminal Disclaimer may be filled out completely online using web-screens, respectively.
Also, the inventor or joint inventor should further note that an eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission.
Finally, for more information about eTerminal Disclaimers, the inventor or joint inventor should refer to http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Allowable Subject Matter
No claims are allowed.
Conclusion
The inventor’s or joint inventor’s arguments and/or the Amendments to the Claims, filed July 28, 2026, necessitated the new ground of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). The inventor or joint inventor 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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to DOUGLAS M. WILLIS, whose telephone number is 571-270-5757. The Examiner may normally be reached on Monday thru Thursday from 8:00-6:00 EST. The Examiner is also available on alternate Fridays.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Mr. Jeffrey Murray, may be reached on 571-272-9023. The fax phone number for the organization where this invention or proceeding is assigned is 571-273-8300.
Information regarding the status of an invention may be obtained from Patent Center. For more information about Patent Center, see https://www.uspto.gov/patents/apply/patent-center. Should you have questions on access to Patent Center, contact the Patent Electronic Business Center (PEBC) at 866-217-9197 (toll-free) or ebc@uspto.gov.
/DOUGLAS M WILLIS/
Primary Examiner, Art Unit 1624
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