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 .
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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 9,730,956 (‘956). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘956 patent discloses a liquid nitric oxide releasing solution (NORS) comprised of at least one nitric oxide releasing compound and at least one acidifying agent, wherein the NORS provides an extended release of a therapeutically effective amount of nitric oxide gas (gNO), wherein the gNO is released over a period of at least 30 minutes, wherein the amount of the at least one nitric oxide releasing compound is not greater than about 0.5% w/v, and wherein the amount of the at least one acidifying agent is no greater than about 0.5% w/v.
Thus, it would have been obvious to one of ordinary skilled in the art at the time the invention was made to obtain the claimed invention given the claims of the ‘956 patent. This is because the ‘956 patent discloses a liquid nitric oxide releasing solution similar to that of the present invention.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 10,905,712 (‘712), in view of US 9,445,996 (‘996). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘712 patent discloses a liquid nitric oxide releasing solution (NORS) comprising at least one nitric oxide releasing compound and at least one acidifying agent, wherein the NORS provides an extended release of a therapeutically effective amount of nitric oxide gas (gNO), wherein the gNO is released over a period of at least 30 minutes, and wherein either the amount of the at least one nitric oxide releasing compound is not greater than about 0.5% w/v, or the amount of the at least one acidifying agent is not greater than about 0.5% w/v, and wherein the NORS has a pH of from about 1 to about 4 during gNO release. Therapeutic concentration is found in claim 8. The claimed release rates are found in claims 10-13.
The ‘712 patent does not expressly teach storing the NO and the acidifying agent separately. However, such limitation is known in the art. See for example the teaching in the ‘996 patent at column 2 and claim 1.
Thus, it would have been obvious to one of ordinary skill in the art at the time the invention was made to obtain the claimed invention given the claims of the ‘712 patent in view of the teaching in the ‘996 patent. This is because the ‘712 patent discloses a liquid nitric oxide releasing solution similar to that of the present invention, namely, a liquid composition comprising at least one nitric oxide releasing compound and at least one acidifying agent, and this is because the ‘996 patent teaches keeping the NO and the acidifying agent separately to prolong the release of NO and to provide a more stable form of NO composition.
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)(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 1 is rejected under 35 U.S.C. 102(a)(2) as being anticipated by Chen et al. US 9,445,996.
Chen teaches a microencapsulated nitrite salt and an aqueous acidified gel with sufficient acidity to convert the nitrite salt to nitric oxide. A reductant to help retain the nitric oxide in bioactive form is preferably included in the gel. The acidifying agent is preferably an organic acid such as citric acid, although inorganic acids such as boric acid, for example may also be suitable. Other acidifying agents may include lactic acid, glyceric acid, formic acid or other organic acids known to those of skill in the art. Inorganic acids with the appropriate pKa values can also be used if they are biologically acceptable (e.g. the aforementioned boric acid). The gel acidifying agent may also be a reductant, such as ascorbic acid (vitamin C) or an ascorbic acid derivative including but not limited to, 3-O-ethyl ascorbic acid, other 3-alkyl ascorbic acids, 6-O-octanoyl-ascorbic acid, 6-O-dodecanoyl-ascorbic acid, 6-O-tetradecanoyl-ascorbic acid, 6-O-octadecanoyl-ascorbic acid, and 6-O-dodecanedioyl-ascorbic acid. The preferred reductant is one having the reductive capability of preventing or slowing the oxidation of nitric oxide to nitrogen dioxide and also having the capability of directly reducing NO.sub.2 to NO so that the gas released by the composition is predominantly NO. Preferred reductants include ascorbic acid, ascorbic acid derivatives, ascorbate salts, tocopherol, erythrobates or alpha-tocopherol. Gelling agents include substances such as hydroxymethyl cellulose, hydroxyethyl cellulose, gelatin, agar, natural gums, starches and pectins. Another embodiment of this invention is a kit for delivering an acidified gel and a microencapsulated nitrite salt. The acidified gel and the microencapsulated nitrite salt are individually packaged in moisture-proof packages, which are opened and their contents mixed together immediately prior to application of the mixture. In an alternative embodiment, the microencapsulated nitrite salt and the acidifying agents are packaged either together or individually in moisture-proof packages. The packages are opened and their contents are mixed with a measured amount of water or a pH-neutral aqueous gel prior to application of the mixture. See columns 4-5 and Claims.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUSAN T TRAN whose telephone number is (571)272-0606. The examiner can normally be reached on Monday-Friday, 8:30 am-5:30 pm.
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/SUSAN T TRAN/Primary Examiner, Art Unit 1615
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