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 .
Priority
The instant application is the national stage entry of PCT/EP2022/077400 filed 30 September 2022. Acknowledgement is made of the Applicant’s claim of foreign priority to application GB2114307.8 filed 6 October 2021.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-18, in the reply filed on 30 March 2026 is acknowledged. The Applicant has canceled claim 56 so no claims are withdrawn.
Status of the Claims
Claims 1-18 are pending.
Claims 1-18 are rejected.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 1-2, 4-5, and 8-18 are rejected under 35 U.S.C. 103 as being unpatentable over Jezek et al. (US 2011/0070318) in view of Aspioti et al. (WO2021/198461).
Jezek teaches a skin dressing, for use in treating a wound, comprising a first source of protons, a nitrite salt, and a non-thiol reductant wherein when the components are brought together and applied to the skin, nitric oxide is generated and exhibits a self-regulation of pH [0013-0017]. One suitable reductant can be an iodide anion in 0.1-5% by weight [0032-0033]. The nitrite salt can be sodium nitrite [0073]. The composition can comprise a carrier of a hydrated hydrogel wherein the hydrogel can include poly 2-acrylamido-2-methylpropane sulphonic acid (poly-AMPS), a diacrylamide crosslinker [0034-0037]. The hydrated hydrogel is typically a solid layer, sheet, or film that is cross-linked [0043]. The wound treatment can be stored in a container with separate compartments or on a prepared dressing [0047-0049]. The components can be stored prior to use in sterile, sealed, water-impervious packages [0050]. Jezek further teaches that although nitric oxide may exert good antimicrobial properties, it does not have vasodiliating properties nor is it capable of activation of the cell proliferation and thus it is generally desirable to stop the direct generation of nitrogen dioxide by incorporating the reducing agent.
Jezek does not teach the hydrogel comprising diacrylamide and sodium isoascorbate.
Aspioti teaches that wound dressings can include a reducing agent to facilitate reduction of the nitric oxide-releasing agent (nitrite ion) to nitric oxide [0121]. Said reducing agent can be selected from iodide anion, ascorbic acid, and isoascorbates [0121].
It would have been prima facie obvious to prepare the wound dressing of Jezek wherein the dressing comprises sodium nitrite, a non-thiol reducing agent such as iodide anion, and a carrier such as poly-AMPS. It must be remembered that “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious.” KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976)). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious,” the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR at 1741. The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742. Consistent with this reasoning, it would have been obvious to have selected various combinations of nitrites, reductants, and carriers from within a prior art disclosure, to arrive at compositions “yielding no more than one would expect from such an arrangement.”
It would have been prima facie obvious to substitute the ionide anion of Jezek with a different reducing agent such as sodium isoascorbate of Aspioti. The presence of the reducing agent serves to prevent the formation of nitrogen dioxide, thus rendering obvious any ratio of nitric oxide to nitrogen dioxide greater than 1, reading on instant claims 8-9 and 16. Generally, it is prima facie obvious to substitute one equivalent component or process for another, each of which is taught by the prior art to be useful for the same purpose (see MPEP 2144.06).
Regarding instant claims 10-15, these claims recite properties associated with the hydrogel component and the diacrylamide crosslinker and also oxygen scavenging ability of isoascorbate. The properties claimed in said claims are considered necessarily present in a hydrogel formed from poly-AMPS, which is identified in the instant specification as being a suitable hydrogel component [0163], and in compositions comprising isoascorbate. It is noted that “products of identical chemical composition cannot have mutually exclusive properties.” A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990) (see MPEP 2112.01 (II)).
Jezek teaches storage in sterile, sealed, water-impervious packages which implies vacuum packed components and exclusion of oxygen, addressing instant claim 2. The presence of sodium isoascorbate further provides oxygen scavenging properties to the composition within the package, as required in claims 4-5.
The resulting wound dressing comprising sodium isoascorbate as the reducing agent renders obvious instant claims 1-2, 4-5, and 8-18.
Claims 1-2 and 4-18 are rejected under 35 U.S.C. 103 as being unpatentable over Jezek et al. (US 2011/0070318) in view of Aspioti et al. (WO2021/198461) in view of Jezek et al. (US 2009/0081279).
Jezek and Aspioti, as applied supra, are herein applied in their entirety for their teachings of a wound dressing comprising sodium nitrite, sodium isoascorbate, and a hydrogel.
Jezek does not teach wherein the nitrite composition has a dissolved oxygen content of less than 250 ppb.
Jezek ‘279 teaches that nitric oxide is a short-lived, unstable gaseous substance [0002] but also teaches that it is stable when stored in pure deoxygenated aqueous solutions [0004].
The purpose of the composition of Jezek is to combine agents to form nitric oxide when applied to the skin as a wound dressing. Since nitric oxide is known to be unstable when exposed to oxygen, it would have been obvious to store the wound dressing composition of Jezek in pure deoxygenated aqueous solution prior to administration so that oxygen is not introduced when applying the dressing to the wound. Jezek ‘279 teaches that nitric oxide is stable in pure deoxygenated water, thus there is a reasonable expectation that the nitric oxide produced by the composition of Jezek will have a longer and stronger effect if oxygen is limited or eliminated. Thus, it would have been prima facie obvious to store the composition of Jezek in completely deoxygenated water, which would imply a dissolved oxygen content of less than 250 ppb. Claims 1-2 and 4-18 are accordingly rejected as obvious in view of the prior art.
Claims 1-18 are rejected under 35 U.S.C. 103 as being unpatentable over Jezek et al. (US 2011/0070318) in view of Aspioti et al. (WO2021/198461) in view of Jezek et al. (US 2009/0081279) in view of Sinyagin (US 2004/0015115).
Jezek, Aspioti, and Jezek ‘279, as applied supra, are herein applied in their entirety for their teachings of a wound dressing comprising sodium nitrite, sodium isoascorbate, and a hydrogel.
Jezek does not teach wherein the wound dressing is packaged in an inert gas.
Sinyagin teaches wound treatments and dressings that may be packaged in a sterile and hermetic packaging [0002, 0072]. The package may be vacuum packed or filled with an inert gas to eliminate possibility of oxidation [0072].
It would have been prima facie obvious to prepare the wound dressing of Jezek, Aspioti, and Jezek ‘279 and package said composition in sterile, sealed, water-impervious packages as taught in Jezek. It would have been further obvious to either vacuum fill the package or fill it with an inert gas to avoid oxidation, as taught in Sinyagin. Claims 1-18 are accordingly obvious in view of the prior art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW S ROSENTHAL whose telephone number is (571)272-6276. The examiner can normally be reached M-F 8-5pm EST.
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, Brian Kwon can be reached at 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ANDREW S ROSENTHAL/ Primary Examiner, Art Unit 1613
Prosecution Insights