DETAILED ACTION
Claims 1-11, 17-21, 29-39, 45-47 and 55 are currently pending. Claims 29-36, 38-39, 45-47 and 55 are currently under examination.
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 .
Election/Restrictions
Applicant’s election without traverse of Group II in the reply filed on 12/08/2025 is acknowledged.
Claims 1-11 and 17-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/08/2025.
Applicant’s election without traverse of metrifonate and chitinase-3-like protein 1 (CHI3L1) in the reply filed on 12/08/2025 is acknowledged.
Claim 37 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/08/2025.
Priority
The instant application claims priority to provisional application 63/437,996, filed 01/09/2023.
Information Disclosure Statement
Applicant’s Informational Disclosure Statement, filed on 02/28/2025 has been considered. Please refer to Applicant's copy of the 1449 submitted herein.
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.
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.
Claim(s) 29-30, 36, 39 and 45 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2007/0287733 in view of US 2017/0182209 and US 2018/0161388.
Regarding claim 29-30, 39 and 45, the ‘733 publication teaches acetylcholinesterase inhibitors have been found to be useful in the topical treatment of skin diseases and skin problems (abstract). Disorders to be treated include ulcers of the skin caused by impaired blood flow infections, pressure, vasculitis or immunological mechanisms [0016]. Other acetylcholinesterase inhibitors may be equally used [0021] and include metrifonate [0041]. The compounds are applied topically to the site of skin trauma and the topical administration may be a gel [0043]. The formulation administration to the site of the lesion containing acetylcholinesterase inhibitors may be 0.05-2% by weight [0044]. The acetylcholinesterase inhibitor may be applied in the form of a wound dressing [0047]. The acetylcholinesterase inhibitor is applied for inflammatory because of wound healing and can be used to control various inflammatory states of the skin [0048]. Application is taught during the acute phase of inflammation [0059]. In wound healing, two patients who had chronic ulcers or wounds that did not heal became considerably better after treatment for four weeks [0057].
Regarding claim 36, the limitation of wherein the acetylcholinesterase inhibitor activates cholinergic receptor muscarinic 1 is met by the ‘733 publication teaching the elected active agent of metrifonate [0041]. “Products of identical chemical composition can 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 applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
The ’733 publication does not specifically teach a diabetic wound ulcer and an alginate hydrogel (claim 29).
The ‘209 publication teaches a hydrogel with tunable stiffness enhance tissue regeneration and wound healing (abstract). The wound healing is taught to be from diabetic ulcers ([0004], [0007], [0024]). The hydrogel is taught to be an alginate and collagen network [0008]. The wound dressing material contains a bioactive composition [0022]. The ‘209 publication teaches administration of the hydrogel reduces a level of inflammatory factors at the site of the wound [0027]. The wound dressing may include anti-inflammatory agents [0023].
The ’388 publication teaches methods of accelerating wound healing in diabetic subjects (abstract). Inflammation is a major factor in diabetic neuropathy [0005]. Mast cell degranulation in diabetic patients is the main factor associated with skin inflammation and related conditions [0009]. Accelerating the healing of wound means that the mast cell degranulation inhibitor elicits a cellular informant that accelerates or promote healing of the wound. The first phase of wound healing is the inflammatory phase that last for approximately three days and is followed by the proliferative phase that lasts two to three weeks. [0043].
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use the metrifonate as taught by the ‘733 publication in an alginate wound dressing as taught by the ‘209 publication because ‘733 publication teaches the use of metrifonate in wound dressing and the ‘209 publication teaches a specific alginate wound dressing. One of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success as 733 publication teaches the metrifonate to be used to treat inflammation in ulcers used in a wound dressing and the ‘209 publication teaches a wound dressing to treat diabetic ulcers which contains anti-inflammatory agents. Thus, it would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use an anti-inflammatory agent used to treat ulcer in a wound dressing material known to contain anti-inflammatory agents to treat ulcers. It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to apply the wound dressing during the inflammation phase as the ‘388 publication teaches the treatment of diabetic wound ulcers during the inflammation phase using a wound dressing and the ‘733 publication teaches metrifonate to treat inflammation and may be placed in a wound dressing. Thus it would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to apply an anti-inflammation wound dressing taught by the ‘733 publication during the inflammation phase of a diabetic wound ulcer as taught by the ‘388 publication.
Claim(s) 35 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2007/0287733 in view of US 2017/0182209 and US 2018/0161388 as applied to claims 29-30, 36, 39 and 45 above, and further in view of US 2014/0227342.
As mentioned in the above 103 rejection, all of the limitations of claims 29-30, 36, 39 and 45 are taught by the combination of the ‘733 publication, the ‘209 publication and the ‘388 publication.
The combination of references does not specifically teach the application the diabetic ulcer wound in an amount sufficient to result in an accumulated concentration of metrifonate in the wound below 1000 micrograms/ml (claim 35).
The ‘342 publication teaches effective amounts of acetylcholinesterase inhibitor (abstract). The acetylcholinesterase inhibitor may be from about 0.001 ug/ml to 2 ug/ml of the composition [0017] and wherein the effective amount is intended to be the amount in the compound and/or composition that is effective to achieve its intended purpose.
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use known amounts of acetylcholinesterase inhibitors for topical formulations and optimize to obtain the desired effects as the ‘733 publication teaches topical application of acetylcholinesterase inhibitors in a concentration range in wt% and the ‘342 publication teaches effective amounts of acetylcholinesterase inhibitors to be used topically in ug/ml. One of ordinary skill in the art before the filing date of the claimed invention would be motivated to optimize the amounts of acetylcholinesterase inhibitors as the ‘342 publication and the ‘733 publication teaches ranges known to be used in topical formulations and the ‘342 publication teaches that effective amounts are the amount needed to achieve its intended purpose wherein the ‘733 publication teaches the intended purpose to be treatment of wounds.
That being said and in lieu of objective evidence of unexpected results, the dosage can be viewed as a variable which achieves the recognized result of successfully treating a specific patient. The optimum or workable range of dosing can be accordingly characterized as routine optimization and experimentation (see MPEP 2144.05 (II)B). “[Discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” In re Boesch, 617 F.2d 272, 276 (CCPA 1980). Appellants provide no evidence of any secondary consideration such as unexpected results that would render the optimized amounts of dosage nonobvious.
Claim(s) 31-32 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2007/0287733 in view of US 2017/0182209 and US 2018/0161388 as applied to claims 29-30, 36, 39 and 45 above, and further in view of Kiaee (IDS dated 02/28/2025).
As mentioned in the above 103 rejection, all of the limitations of claims 29-30, 36, 39 and 45 are taught by the combination of the ‘733 publication, the ‘209 publication and the ‘388 publication.
Kiaee teaches laponite based nanomaterials for drug delivery (title). Laponite is a clay-based material composed of synthetic disc-shaped crystalline nanoparticles with large and highly ionic surface area that enable dissolution of biomolecules in Laponite based drug delivery systems. Laponite’s coagulation capacity and cation exchangeability determine its exchange capacities, dug encapsulation efficiency and release profile and have been exploited to design highly controlled and efficacious drug delivery platforms for sustained rug release (abstract). The release is taught for uncharged nonpolar, aromatic or alkyl groups and hydroxyl groups. This shows a broad range of molecules can interact with laponite and firms the extensive potential as drug carrier (page 4, second paragraph). Hybrid clay-based material have gained increasing attention for sustained delivery of therapeutic owing to inherent properties showed by this material, including large surface area, decreased toxicity and high absorption capacity (page 14, last paragraph). Deliver of anti-inflammatory molecules taught and use in wound healing composition (page 18,2nd to last and last paragraph).
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use laponite as taught by Kiaee in the compristion taught by the combination of references because the ‘733 publication teaches topical delivery of anti-inflammatory agents and laponite is taught to be used with anti-inflammatory agents and with wounds, wherein the active agents used for controlled delivery with laponite is taught to be a broad range. It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use laponite in the composition taught by the combination of references as the ’733 publication teaches the desire to control drug delivery rate at the lesion site and Kiaee teaches laponite is used as a drug carrier to decrease toxicity and have sustained controllable drug release.
Claim(s) 32-33 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2007/0287733 in view of US 2017/0182209 and US 2018/0161388 as applied to claims 29-30, 36, 39 and 45 above, and further in view of US 2016/0296472.
As mentioned in the above 103 rejection, all of the limitations of claims 29-30, 36, 39 and 45 are taught by the combination of the ‘733 publication, the ‘209 publication and the ‘388 publication.
The combination of references does not specifically teach wherein the metrifonate is encapsulated in a plurality of polymer microspheres (claim 33) wherein the polymer microspheres comprise poly lactide-co-glycolide (claim 34).
The ‘472 publication teaches multi-layered microspheres can be used to control the release of different drugs encapsuled into different layers. The initial rapid release of the therapeutic agent is to be followed by a more steady release of a second therapeutic agent over a longer period. The microsphere of slow stable release is taught to be PLGA. Wound filler material is taught to use the microspheres to include a fast release of an antibiotic and a slower release of an anti-inflammatory agent [0098].
It would be prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to encapsulate the active agent as taught by the ‘733 publication in a microsphere as the ‘472 publication teaches the use of PLG microspheres to control the drug release rate in wound treating composition. One of ordinary skill in the art before the filing date of the claimed invention would be motivated and have an expectation of success to use the microparticles of the ‘472 publication for drug release in the composition taught by the combination of references as the ‘472 publication teaches the desire to release an antibiotic rapidly followed by controlled release of an anti-inflammatory agent wherein the ‘733 publication teaches the release of an anti-inflammatory agent to treat wounds wherein additionally active agents may be used [0043].
Claim(s) 46 and 55 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2007/0287733 in view of US 2017/0182209 and US 2018/0161388 as applied to claims 29-30, 36, 39 and 45 above, and further in view of US 4,563,184.
As mentioned in the above 103 rejection, all of the limitations of claims 29-30, 36, 39 and 45 are taught by the combination of the ‘733 publication, the ‘209 publication and the ‘388 publication.
The ‘388 publication teaches the first phase of wound healing is the inflammatory phase which lasts about three days and is followed by the proliferative phase that lasts two to three weeks [0043]. Daily application of the topical substance to the wound is taught up to 10 days [0068].
The ‘733 publication teaches treatment consisting of applying a gel containing the active compound for two days twice daily [0055].
The combination of references does not specifically teach applying a further wound dressing to the wound after the inflammatory phase (claim 46) and wherein the further wound dressing is applied during the proliferation phase of healing of the wound (claim 55).
The ’431 patent teaches synthetic resin wound dressing. The wound dressing contains a variety of drug agents and is time released administration of the drug to the area of the skin covered by the wound dressing (abstract). The wound dressing may comprise anti-inflammatory drugs (column 3, lines 63-67). The wound dressing were taught to be changed every 4 days so that each test animal received 5 dressings (Example 15).
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to apply wound dressings for multiple days and then replace with an addition wound dressing as the ‘388 publication teaches application up to 10 days in diabetic wound healing and the ‘431 patent teaches that is known to reapply wound dressing every four days, thus reapplication of the wound dressing taught by the combination of the ‘733 publication and the ‘209 publication would be reapplied more than once during the diabetic wound healing time as taught by the ’388 publication and the ’431 patent. It would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to reapply wound dressings as the ‘733 publication teaches the desire for daily application of the active agent during wound healing and the ‘431 patent teaches for active agent administering wound dressing to be changed every 4 days during the healing period. One of ordinary skill in the art would have a reasonable expectation of success as the ‘431 patent teaches the wound dressing to contain anti-inflammatory agents and the ‘733 publication is taught to contain anti-inflammation agents in a wound dressing.
Regarding the application after the inflammatory phase, the ‘388 publication teaches the inflammatory phase to last 3 days followed by the proliferation phase and the ‘431 patent teaches changing of the wound dressing after 4 days for a period of up to 20 days, thus teaching application at the inflammation period for a first dressing and at the proliferation period for a second dressing.
Claim(s) 47 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2007/0287733 in view of US 2017/0182209 and US 2018/0161388 as applied to claims 29-30, 36, 39 and 45 above, and further in view of WO 2019/025431 (Applicant provided IDS dated 02/28/2025).
As mentioned in the above 103 rejection, all of the limitations of claims 29-30, 36, 39 and 45 are taught by the combination of the ‘733 publication, the ‘209 publication and the ‘388 publication.
The combination of references does not specifically teach further wound dressing comprise a recombinant RNA molecule encoding one or more polypeptide selected form the group include FGF-2 (claim 47).
The ‘431 publication teaches a mRNA encoding FGF2 and its use in the treatment of skin diseases such as e.g. diabetic foot ulcer (abstract, page 1, last para page 21, para 2, page 80, para 3-4, page 81, para 4-page 82, para 2). The mRNA encoding FRF2 can be modified o not and contains 5’CAP region, a 5’UTR region and a coding region for FGF2, a 3’UTR and a polyA tail (page 17, para 3). Modified FGF2 mRNAs that comprise e.g. 5-methyl-cytidine reduces and/or pseudoridine residues (page 29, para 4-page 30, para 3). Topical application is taught (page 25, second to last para).
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to include mRNA as taught by the ‘431 publication in the wound dressing as taught by the combination of the ‘733 publication and the ‘209 publication because the ‘733 publication teaches a composition for treating diabetic wound ulcers for topical application and the ‘431 publication teaches mRNA for treating diabetic foot ulcers. One of ordinary skill in the art before the filing date of the claimed invention would have motivation and expectation of success as the ‘733 publication and the ‘431 publication are both directed to treating diabetic foot ulcers topically and the ‘733 publication teaches additionally gets may be used in the compristion. “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
Claim(s) 38 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2007/0287733 in view of US 2017/0182209 and US 2018/0161388 as applied to claims 29-30, 36, 39 and 45 above, and further in view of HyTape (HyTape, https://hytape.com/, 11/22/2021, pgs. 1-9).
As mentioned in the above 103 rejection, all of the limitations of claims 29-30, 36, 39 and 45 are taught by the combination of the ‘733 publication, the ‘209 publication and the ‘388 publication.
The ‘388 publication teaches the wound being a food ulcer for a diabetic wound ([0009], [0012]).
The combination of references does not specifically teach further comprising an adhesive layer to attach the wound dressing to the skin surrounding the diabetic wound (claim 38).
HyTape teaches diabetic ulcers require proper wound dressings and practicing good wount care for the healing processes. While there are a variety of wound dressing for diabetic ulcers and sores, proper adhesion of the dressing is vital. Hy-Tape is waterproof adhesive tape that holds tight without irritating the skin and can be easily replaced when needed (page 1, first and second paragraph).
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use an adhesive such as Hy tape for adhesion of the wound dressing taught y the ‘733 publication and the ‘209 publication because the combination of references teaches wound care dressing which is applied to diabetic ulcers and HyTape teaches the use of HyTape as an adhesive to apply a wound dressing to diabetic foot ulcers. One of ordinary skill in the art before the filing date of the claimed invention would be motivated to use HyTape to promote good adhesion of the wound dressing without skin irritation and easy replacement.
Conclusion
No claims are allowed.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNDSEY MARIE BECKHARDT whose telephone number is (571)270-7676. The examiner can normally be reached Monday-Thursday 9am to 4pm and Friday 9am to 2pm.
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/LYNDSEY M BECKHARDT/ Examiner, Art Unit 1613