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.
Claims 1-3 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 9,730,956 (‘956), in view of US20110070318 A1 (‘318). 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. Sodium nitrite is found in claim 3. Citric acid is found in claim 5. Method for treating wound is found in claim 12.
It is noted that the ‘956 patent does not expressly teach a cover for the wound treating composition. However, such feature is known in the art for wound treating composition. See for example the teaching in the ‘318 reference at paragraphs 0001, 0017 and claims.
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, in view of the teaching in the ‘318 reference. This is because the ‘956 patent discloses a liquid nitric oxide releasing solution similar to that of the present invention, and this is because the ‘318 reference teaches a wound healing composition comprising nitic oxide in a form of a patch comprising a backing and/or covering layer is known in the art.
Claims 1-3 are 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 US20110070318 A1 (‘318). 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.
It is noted that the ‘712 patent does not expressly teach a cover for the wound treating composition. However, such feature is known in the art for wound treating composition. See for example the teaching in the ‘318 reference at paragraphs 0001, 0017 and claims.
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 ‘712 patent, in view of the teaching in the ‘318 reference. This is because the ‘712 patent discloses a liquid nitric oxide releasing solution similar to that of the present invention, and this is because the ‘318 reference teaches a wound healing composition comprising nitic oxide in a form of a patch comprising a backing and/or covering layer is known in the art.
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)(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.
Claims 1-3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jezek et al. US 20110070318 A1.
Jezek teaches a skin dressing is provided comprising a first component comprising a source of protons, a second component comprising a nitrite salt, the dressing comprising a non-thiol reductant, such that, when the first and second components are brought together and applied to a skin site the nitrite reacts to generate nitric oxide, increasing the pH of the dressing in contact with the skin from an acidic value to a more neutral value. See Abstract. The dressing, typically in use on skin, thus functions as a nitric oxide donor, nitric oxide is being released on or in the vicinity of the skin being treated. This can be achieved whilst avoiding prolonged exposure of the body site (skin, wound etc.) to an acidic, strongly buffered, dressing application. See paragraph 0017.
Claims 1-3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Benjamin US 20100015253 A1.
Benjamin teaches a nitrogen oxide generating composition may take any suitable form. However, it will be appreciated that, where the generation of nitrogen oxides is active, then the reactants should be kept separate one from the other until nitrogen oxide is actually required. Although this is generally a preference, it need not necessarily always apply. For example, an occlusive patch may be constructed with a gel, or matrix, into which nitrogen oxide generating ingredients are loaded, the patch then being protected by a suitable webbing to prevent gaseous release. In such a patch, it is preferred that the matrix or gel is adhesive, and that the strength of the adhesion is sufficient to overcome any tendency of the nitrogen oxide to escape and push away the webbing, although it will be appreciated that the strength of the adhesive should not be such that the webbing cannot be satisfactorily removed to allow application of the patch. Further, it is preferred to provide suitable stabilisers, such as chelating agents, in the gel or matrix, in order to prolong the life of the NO or to reduce the rate at which it is produced. Additionally, as NO is more soluble in non-aqueous and lipid substances, the addition of such substances to the treatment may prolong the activity and delivery of NO to the affected nail and nail bed. See paragraphs 0033-0034. Transdermal patch with cover and backing layers is found in paragraphs 0048-0053. Acidifying agent is found in paragraphs 0062-0063.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, ROBERT A. WAX can be reached on 571-272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SUSAN T TRAN/Primary Examiner, Art Unit 1615
Prosecution Insights