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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 07/14/2025 has been entered.
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 1-23 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). 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.
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.
Claims 1-14 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). 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.
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. 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.
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.
Claims 1-23 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Stenzler et al. US 2015/0157657 A1.
The applied reference has a common inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C.102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
This rejection has been withdrawn in view of Applicant’s Remarks filed 05/21/2025.
(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 1-21 and 23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Miller et al. US 2012/0003293 A1.
This rejection has been withdrawn in view of the Amendment filed 05/21/2025.
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.
Claims 1-23 are rejected under 35 U.S.C. 103 as being unpatentable over Kross et al. US 2003/0175362 A1, in view of Miller et al. US 20120003293 A1.
Kross teaches a composition comprises a topical wound healing aqueous solution containing a suitable amount of a protic acid, or a material inducing an acidic environment therein, and a suitable amount of a nitrite salt. See paragraph 0017. Nitrite salt includes sodium nitrite is found in paragraph 0030 and Claims. Acid includes citric acid is found in claim 6. Example 1 shows saline used in aqueous solution containing nitrite salt. Disinfecting solution is found in paragraph 0086. Nitrite salt such as sodium nitrite present in the solution in a concentration ranging from about 0.01% to about 1% is found in claim 2. This teaching falls within the claimed range of about 12 ppm to 400 ppm (0.012% to 0.04%). Concentration of the acid agent is found in Claim 7.
Kross does not teach the composition provides an extended release property.
Kross teaches an aqueous gel or water activation wound dressing composition. The activation may, for example, be triggered by the user or by a care giver. The aqueous gel or water may, for example, come from hydro-gel capsules or breakable packets. Post-release the aqueous gel or water will mingle with the sodium nitrite, citric acid, and oxygen-releasing compound to produce NO. See paragraph 0014. The present dressings comprise a source of gaseous NO. The source may comprise sodium nitrite and citric acid. The reaction between sodium nitric and citric acid may be catalyzed by the presence of an aqueous gel or water. Accordingly, the present invention preferably comprises a source for an aqueous gel or water. The source may comprise hydro-gel capsules or packets comprising an aqueous gel. The hydro-gel capsules or packets may be configured so as to release the aqueous component upon the controllable activation of a device by the user. A suitable device for activating the aqueous component may comprise a pull tab attached to the hydro-gel capsules, which when pulled, breaks the capsules to release the inner aqueous component. Such device may also comprise aqueous gel or water packets, such packets being broken to release the inner aqueous component by applying pressure over the wound dressing. The commingling of the sodium nitrite, citric acid, and aqueous component produces gaseous NO which can diffuse through at least a portion of the wound dressing. Application of the wound dressing or bandage over a surface or subsurface lesion may also result in subsequent absorption of liquid into the dressing from the wound, which could act as a further catalyst for the NO-producing reaction. See paragraph 0041. Firg. 5 shows the time release that falls within the claimed range.
Thus, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to, by routine experimentation select to control the release of the active agent with the expectation to provide therapeutic treatment to the wound with improved patient compliance, convenience in view of the prolonged protection to the wound site.
Response to Arguments
Applicant’s arguments filed 07/14/2025 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
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/SUSAN T TRAN/Primary Examiner, Art Unit 1615