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 .
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.
Claim Status
Applicant’s remarks of 08/12/2025 are acknowledged. No claim amendments were submitted with the response. Claims 1-28, 30-39, and 41-42 are currently pending.
Election/Restrictions
A restriction/species election was required in the instant application as detailed in the Office Action dated 04/20/2023. The election is maintained and claims 5, 16, 21-28, 30-39, and 42 remain withdrawn.
Accordingly, claims 1-4, 6-15, 17-20, and 41 are examined on the merits herein.
Priority
The instant application claims domestic benefit to U.S. Application No. 63/012,036 filed on 04/17/2020 as reflected in the filing receipt dated on 04/28/2021.
Information Disclosure Statement
The information disclosure statemen (IDS) submitted on 08/12/2025 IDS Considered is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Withdrawn Objections and Rejections
Applicant’s amendments to the claims have overcome the previous objection to the claims. Thus, the objection is hereby withdrawn.
Applicant’s arguments with respect to the previous 112(a) rejections were found to be persuasive. Therefore, the rejections are hereby withdrawn.
Applicant’s amendments to the claims have overcome/rendered moot the previous 112(b) rejections. Thus, the rejections are hereby withdrawn.
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.
Claims 1-4, 6-8, 11-15, 18, and 41 are rejected under 35 U.S.C. 103 as being unpatentable over Suhaeri et al. 2018 (PTO-892 of 02/12/2025) in view of Spero et al. 2018 (IDS of 09/08/2021) and Walters et al. 2003 (PTO-892 of 02/12/2025).
Suhaeri teaches that wound healing is a complicated but highly regulated biological event involving specific immune cells, tissue cells, and a variety of cytokines and growth factors (Pages 5025-5026). Wounds recover structural integrity and function via interactions among cells, growth factors, and extracellular matrix (ECM), yet bacterial infection is often problematic and can lead to a chronic wound (Page 5026). Thus, Suhaeri discloses a novel skin wound patch that physically combines cell-derived ECM and an antibacterial agent together (Page 5026). Biocompatible polyvinyl alcohol (PVA) hydrogel was used to deliver ciprofloxacin and human lung fibroblast-derived matrix (hFDM), hereafter PVA/Cipro/hFDM, to facilitate wound healing in infected skin wound animal models (Page 5026). hFDM itself contains many angiogenic factors, such as basic fibroblast growth factor and hepatocyte growth factors, among others, which read on the wound healing agent of instant claim 8 (Page 5036).
Aqueous PVA was added onto hFDM followed by crosslinking of the PVA hydrogel (Page 5026). Ciprofloxacin was then incorporated into the PVA/hFDM membrane at concentrations of 1, 10, and 20 mg/mL, indicating that the antibiotic was embedded into the delivery matrix (Page 5026 and Fig. 1A). Inclusion of ciprofloxacin inside PVA hydrogel is based on drug uptake during the hydrogel swelling process, and the drug loading efficiency was around 8% (Page 5029). To investigate the antibacterial efficacy, a total of four gram-negative and -positive bacterial strains were employed for zone inhibition assay: Escherichia coli, Pseudomonas aeruginosa, Staphylococcus epidermidis, and Staphylococcus aureus (Page 5028). The capability of ciprofloxacin-containing PVA membranes to kill bacteria was excellent and comparable, whereas membranes without ciprofloxacin showed no bacterial inhibition with the exception of PVA against E. coli, which is known to be susceptible to acidic pH (Page 5031).
A skin wound model infected with S. aureus was prepared and subsequently treated with PVA, PVA/Cipro, and PVA/Cipro/hFDM by surgically applying the patch application to the wounded mouse (Pages 5028 and 5032, and Fig. 5A). Treatments with PVA/Cipro and PVA/Cipro/hFDM exhibited no microbial activity in contrast with control and PVA groups where the number of bacteria was significantly high, as well as smaller wound size over time (Page 5032 and Fig. 5A-C). At 3 weeks post-treatment, reepithelialization and advanced wound healing was apparent, with PVA/Cipro/hFDM showing wound generation similar to the unique features of normal skin, including skin adnexa and relative thickness of the neoepidermis (Page 5032 and Fig. 6A). Further, wounds treated with PVA/Cipro/hFDM present a distinct pattern of collagen texture and distribution similar to that of normal skin (Page 5033 and Fig. 7B) and upregulation of Cx43 expression, which is a gap junction protein important for dermal fibroblast migration, vascularization of endothelial cells, and angiogenesis (Page 5036).
Together, the teachings of Suhaeri show that PVA/Cipro/hFDM skin wound patch has a wide range of antibacterial activity against gram-negative and -positive bacteria, including P. aeruginosa, and exhibits advanced wound regeneration, making it a promising candidate for treating infected wounds and promoting skin regeneration (Page 5037).
Suhaeri does not teach that the skin wound patch comprises one or more chlorates.
Spero teaches that P. aeruginosa infections are known to contribute to chronic wounds (Page 2). However, nontoxic chlorate can be reduced to chlorite, a toxic reactive oxidizing agent, by the respiratory nitrate reductase, Nar, in P. aeruginosa (Page 3). Chlorate and the antibiotic tobramycin kill distinct metabolic populations in P. aeruginosa biofilms, where chlorate targets anaerobic cells that tolerate tobramycin (Abstract). Specifically, an agar block biofilm assay (ABBA) was used to study aggregate biofilms were either untreated or treated with either 40 µg ml-1 tobramycin, 10 mM sodium chlorate, or both compounds (Pages 8 and 13). 10 mM sodium chlorate falls within the instantly claimed range of chlorate recited in instant claim 2. Cells in surface aggregates were killed by tobramycin, whereas those at depth were tobramycin tolerant; however, chlorate targeted aggregates at depth and the interior of middepth aggregates, whereas surface aggregates and the exterior of middepth aggregates were chlorate tolerant (Page 8 and Fig. 5B). Because tobramycin treatment perturbs the biofilm microenvironment by increasing oxygen penetration, which increases bacteria survival and removes chlorate sensitivity, Spero hypothesizes that sequential treatment of chlorate then tobramycin, or vice versa, would kill all cells given enough time (Page 10). Of importance, the toxic chlorite by-product of chlorate reduction did not accumulate in planktonic cultures or in anoxic zones of the biofilms, indicating it is not likely to harm neighboring mammalian cells (Page 11).
Walters teaches that the chronic nature of some infections involving the opportunistic pathogen Pseudomonas aeruginosa is that the organism is adept at forming biofilms, which protect the bacteria from host defenses and from killing by antibiotics (Page 317). The efficacy of the antibiotics tobramycin and ciprofloxacin were evaluated against several forms of P. aeruginosa: planktonic cells in suspension, resuspended biofilm cells, and colony biofilms (Page 319 and Fig. 1). Both antibiotics had little effect on the viability of P. aeruginosa in colony biofilms (Page 319 and Fig. 1). When the antibiotic-tolerant bacteria of the colony biofilms are dispersed, their antibiotic sensitivity returns, indicating tolerance is reversible (Page 319). Further testing demonstrated that oxygen limitation and the resulting low metabolic activity in the interior of the biofilm, not poor antibiotic penetration, are correlated with antibiotic tolerance of P. aeruginosa biofilms (Page 322).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the PVA/Cipro/hFDM skin wound patch of Suhaeri by adding the sodium chlorate taught by Spero. One of ordinary skill in the art would have been motivated to add sodium chlorate because Spero teaches that the chronic nature of some infections, specifically those involving P. aeruginosa biofilms, are tolerant to the killing effect of antibiotics, and sodium chlorate is able to target antibiotic-tolerant anerobic cells found within greater depths of biofilms. There is a reasonable expectation of success because Walters teaches that oxygen limitation, not antibiotic penetration, is responsible for P. aeruginosa tolerance of both tobramycin, the antibiotic evaluated in Spero, and ciprofloxacin, the antibiotic in the skin wound patch of Suhaeri. Further, Suhaeri teaches that PVA/Cipro/hFDM exhibited excellent capability in killing P. aeruginosa bacteria. Therefore, one would reasonably expect that sodium chlorate would complement the antibiotic activity of ciprofloxacin in a similar manner to tobramycin to form a wound healing composition embedded in a PVA/hFDM delivery matrix. The composition suggested by the combination of applied references does not include chlorite and, therefore, promotes wound healing in the absence of chlorite.
Regarding the limitations “for treating and/or preventing a bacterial infection in a chronic wound” and “promote wound healing” recited in claims 1, 11, and 18, “reduce antibiotic resistance, viability, and/or survivability of bacteria in the wound” and recited in instant claim 1, and “to treat a systemic and/or chronic bacterial infection” and “treating and/or preventing the systemic and/or chronic bacterial infection”, recited in instant claim 41, the wound healing composition embedded in a skin wound patch taught by the combination of Suhaeri, Spero, and Walters comprises a PVA/Cipro/hFDM skin wound patch known to effectively kill a wide range of gram-negative and -positive bacteria and to promote enhanced wound regeneration, as well as sodium chlorate, which is known to combat antibiotic resistance and effectively kill P. aeruginosa bacteria in biofilms like those found in chronic infections. Together, the wound healing composition embedded in a skin wound patch taught by the combination of Suhaeri, Spero, and Walters would be capable of performing the above claim limitations. Furthermore, it is noted that the limitations recited above are intended uses of the claimed composition. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. Note: MPEP 2111.02.
Regarding the limitation “in an amount suitable” recited in instant claim 1, the instant specification does not disclose a definition for a suitable amount. Because the concentration of ciprofloxacin taught by Suhaeri and the concentration of sodium chlorate taught by Spero resulted in effective killing of bacteria in wounds and biofilms, the amounts taught by the prior art are suitable for reducing antibiotic resistance, viability, and/or survivability in the wound and promoting wound healing, in the absence of chlorite.
Regarding the limitation “biofilm treatment matrix” recited in claim 11, Spero teaches that sodium chlorate combats antibiotic resistance and effectively kills P. aeruginosa bacteria in biofilms like those found in chronic infections. Therefore, the combination of sodium chlorate and ciprofloxacin, as suggested by the combined teachings of Suhaeri, Spero, and Walters, meets the limitation of a “biofilm treatment agent”. Further, the resulting biofilm treatment agent is embedded within a PVA hydrogel-coupled human lung fibroblast-derived matrix to deliver the chlorate and antibiotic to an infected wound, which meets the limitation “biofilm treatment matrix”.
Regarding the limitation “effective amount” recited in instant claims 11 and 18, the instant specification discloses that an "effective amount" of one or more active ingredients refers to a nontoxic but sufficient amount of one or more drugs to provide the desired effect (Page 44). Because the concentration of ciprofloxacin taught by Suhaeri was not found to be toxic to wound-infected mice, and the concentration of sodium chlorate taught by Spero did not result in accumulation of toxic by-product in neighboring cells, the amounts taught by the prior art are nontoxic but sufficient to provide the desired antibacterial and wound healing effects.
Claims 9, 10, 17, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Suhaeri et al. 2018 (PTO-892 of 02/12/2025) in view of Spero et al. 2018 (IDS of 09/08/2021) and Walters et al. 2003 (PTO-892 of 02/12/2025), as applied to claims 1, 8, and 11 above, and further in view of Chen 2016 (CN106344955A; PTO-892 of 04/20/2023).
The combination of Suhaeri, Spero, and Walters teaches the wound healing composition of instant claims 1 and 8, and the biofilm treatment matrix of instant claim 11 as discussed in detail above.
However, the combined teachings of Suhaeri, Spero, and Walters do not teach the specific growth factors or antioxidants claimed, or the elected species of growth factor, EGF, and antioxidant, alpha-tocopherol.
Chen teaches collagen-based surgical dressings comprising both EGF and vitamin E (known as alpha-tocopherol), among other ingredients, wherein EGF promotes the transport of small molecules such as K+ and deoxyglucose, increases the synthesis and secretion of extracellular matrix (ECM), and promotes the synthesis of RNA, DNA and proteins, and vitamin E restores a vitamin deficiency that contributes to skin staining and other skin problems, including chloasma (Page 3). The 3D dressings were designed based on the wound shape and thickness of the patient’s skin and then printed using compositions with varying concentrations of EGF, vitamin E, and other ingredients to produce a skin whitening and speckle-dispelling dressing which were applied to women for wound repair (Pages 7-8, and Embodiments 1 and 3-8).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the wound healing composition embedded in a skin wound patch taught by the combination of Suhaeri, Spero, and Walters by adding the EGF and vitamin E wound repair agents taught by Chen. One of ordinary skill would have been motivated to add EGF and vitamin E to the wound healing composition because Chen teaches that such agents are useful for repairing skin staining and other skin problems, such as chloasma, that can occur at the site of skin wounds. Further, Suhaeri teaches that wounds recover structural integrity and function via interactions among cells, growth factors, and ECM, suggesting that the presence of additional growth factors like EGF, which contributes to synthesis and secretion of ECM as taught by Chen, would be beneficial in promoting wound healing. There is a reasonable expectation of success because Chen teaches the use of compositions comprising EGF and vitamin E in polymer-based skin wound dressings, which is akin to the PVA/hFDM-based skin wound patch taught by the combination of Suhaeri, Spero, and Walters.
Regarding instant claim 20, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the wound healing agents EFG and vitamin E, as taught by Chen, to the wound after contacting the wound with the wound healing composition embedded within a biofilm treatment matrix taught by the combination of Suhaeri, Spero, and Walters. One of ordinary skill would have been motivated to apply the agents subsequently because Chen teaches that such agents are useful for repairing skin staining and other skin problems, such as chloasma, that can occur at the site of skin wounds and, importantly, Suhaeri teaches that wounds recover structural integrity and function via interactions among cells, growth factors, and ECM, suggesting that the presence of additional growth factors like EGF, which contributes to synthesis and secretion of ECM as taught by Chen, would be beneficial in promoting wound healing. There is a reasonable expectation of success because Chen teaches the use of compositions comprising EGF and vitamin E for repairing skin wounds.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Suhaeri et al. 2018 (PTO-892 of 02/12/2025) in view of Spero et al. 2018 (IDS of 09/08/2021) and Walters et al. 2003 (PTO-892 of 02/12/2025), as applied to claims 1 and 18 above, and further in view of Danner et al. 1995 (US5855922A; PTO-892 of 04/20/2023).
The combination of Suhaeri, Spero, and Walters teach the wound healing composition of claims 1 within a biofilm treatment matrix as discussed in detail above.
However, the combined teachings of Suhaeri, Spero, and Walters does not teach administering a therapeutically effective amount of chlorite to the wound prior to contacting the wound with the wound healing composition.
Danner teaches antiseptic compositions comprising solutions of metal chlorite, useful as wound healing agents for the therapeutic treatment of dermal wounds, trauma, burns, dermal infection, non-healing chronic wounds, decubitus ulcers, and the prophylactic prevention of decubitus wounds (Abstract and Col. 5, lines 30-34). Danner teaches that the compositions are applied preferably as soon as possible after the infection, disease, inflammation, etc. appears, and that its compositions include antiseptic properties and low levels of irritation and toxicity, as well as provide quicker healing and increased reduction of scarring (Col. 7, lines 1-12; Col. 5, lines 25-48). Danner gives examples of applying aqueous solution of sodium chlorite to fresh dermal wounds, burns, skin ulcers, dermal pressure wounds, etc. (Examples I-VI).
Regarding instant claim 19, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to administer a therapeutically effective amount of chlorite to the wound prior to contacting the wound with the wound healing composition taught by the combination of Suhaeri, Spero, and Walters. One of ordinary skill in the art would have been motivated to first add chlorite to the wound because Danner teaches that sodium chlorite antiseptic compositions have low levels of irritation and toxicity, promote quicker healing and reduced scarring, and are preferably applied as soon as possible after infection appears. There is a reasonable expectation of success because Danner teaches the use of the composition in treating dermal wounds and dermal infection, as well as for prophylactic prevention of decubitus wounds.
Regarding the limitation “therapeutically effective amount” recited in instant claim 19, while the instant specification does not define a therapeutically effective amount of chlorite specifically, a therapeutically effective amount of chlorate refers to “a non-toxic but sufficient amount of the chlorate to provide the treatment and/or prevention of such condition in the individual”, which can be “identified by a person skilled in the art based on the guidelines and health reference levels provided by health organizations such as WHO and environmental protection agencies such EPA” (Page 44). Therefore, it would be obvious to one of ordinary skill to use the available guidelines for chlorite as a starting point for subsequent optimization to determine the amount of chlorite required to be therapeutically effective.
It is noted that the claims above were rejected based on the elected species sodium chlorate in combination with antibiotics and wound healing agents, wherein the antibiotic is ciprofloxacin and the wound healing agent is the growth factor EGF, the delivery matrix is hydrogels made of PVA, the antioxidant is alpha-tocopherol, and the composition is within a biofilm treatment matrix. However, because claim 1 encompasses alternative components of the composition, including embodiments of the composition wherein only one component need be present, these alternative scopes are also met by the combined teachings of Suhaeri, Spero, and Walters.
Response to Arguments
Applicant’s arguments submitted on 08/12/2025 with respect to rejections under 35 U.S.C. 103 have been fully considered in so far as they apply to the new or modified rejections of the instant Office action, but were not found to be persuasive.
Applicant argues that none of the cited references disclose, teach, or suggest “promotion of wound healing performed in the absence of chlorite.”
Specifically, Applicant asserts that Spero fails to mention wound healing. This argument was not found to be persuasive. First, as discussed at length in the Examiner Interview dated 06/30/2025, the recitation “wound healing” is an intended use of the claimed composition, which must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. Since the structure of the composition taught by the prior art is capable of performing the intended use, then it meets the claim. Note: MPEP 2111.02. Further, one cannot show nonobviousness by attacking references individually (Note: MPEP 2145(IV)), but rather whether the invention is rendered obvious by the teachings of the prior art as a whole (Note: MPEP 2145(III)). The combination of prior art teaches a skin wound patch comprising ciprofloxacin and chlorate that is capable of providing wound healing effects.
Applicant further argues that Spero’s contemplation of the involvement of other chlorine reduction products discourages translation of its results into a wound healing composition or wound-healing biofilm matrix in the absence of chlorite. The Examiner respectfully disagrees. The argument that application of chlorate may result in downstream chlorine reduction products is irrelevant to the structure of the claimed composition, and directly contradicts the examples Applicant cites on Page 20 of the Remarks, which teach that application of chlorate to bacterial infections in vitro or in vivo is sufficient to meet the limitation “in absence of chlorite”. Because Spero teaches the application of chlorate and does not teach the inclusion of chlorite in the composition, it meets the claim. The same logic applies to the other prior art references, which do not teach the use of chlorite.
Applicant then argues that Suhaeri makes no mention concerning the ability of its skin wound patch to achieve wound healing involving growth and tissue regeneration in the individual. This argument was not found to be persuasive. While (1) the term “wound healing” is an intended use of the claimed composition which does not result in a structural difference between the claimed composition and the prior art composition and (2) “growth and tissue regeneration in the individual” are not claimed features, Suhaeri explicitly teaches that its disclosed patch provides more advanced therapeutic benefits toward skin wound healing and investigates its efficacy for wound healing using infected skin wound animal models (Pages 2025-2026, “Introduction”; cited on Page 11 of previous Office action). Clearly, the skin wound patch of Suhaeri is designed to achieve wound healing.
Applicant further argues that the teachings of Walters make no mention of a “wound healing” effect. This argument was not found to be persuasive. While the term “wound healing” is an intended use of the claimed composition which does not result in a structural difference between the claimed composition and the prior art composition, one cannot show nonobviousness by attacking references individually. Walters is concerned with overcoming antibiotic resistance in P. aeruginosa biofilms, which contribute to the chronic nature of some infections (Pages 317 and 319; cited on Page 14 of previous Office action), and is therefore directly relevant to the problem of preventing bacterial infections in chronic wounds, as contemplated by Suhaeri (Page 5026; cited on Page 11 of previous Office action).
Applicant further argues that absent guidance provided in Applicant’s disclosure, a person of ordinary skill in the art would lack a reasonable expectation of success in practicing the claimed methods and compositions. This argument was not found to be persuasive because, as discussed at length in the prior art rejections of record, the wound healing composition embedded in a skin wound patch taught by the combination of Suhaeri, Spero, and Walters comprises a PVA/Cipro/hFDM skin wound patch known to effectively kill a wide range of gram-negative and -positive bacteria and to promote enhanced wound regeneration, as well as sodium chlorate, which is known to combat antibiotic resistance and effectively kill P. aeruginosa bacteria in biofilms like those found in chronic infections. Together, the wound healing composition embedded in a skin wound patch taught by the combination of Suhaeri, Spero, and Walters would be reasonably capable of performing the above claim limitations when applied to a wound using the method of Suhaeri.
Applicant further cites Buyuktimkin et al., which merely recites known characteristics of chlorite, and argues that the preponderance of the evidence of record appears to teach away from the claimed compositions and methods, asserting that they would be expected to be ineffective in the absence of chlorite. This was not found to be persuasive. MPEP 2123(II) states, “The prior art's mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed….' In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004)”. In this case, Buyuktimkin’s disclosure of an alternative wound healing composition does not constitute a teaching away from a known or obvious composition for the same use.
Applicant further argues that none of the cited documents disclose, teach, or suggest the use of an effective amount of chlorate to promote wound healing in the absence of chlorite. This argument was not found to be persuasive under broadest reasonable interpretation and in light of Applicant’s instant specification, which discloses that an "effective amount" of one or more active ingredients refers to a nontoxic but sufficient amount of one or more drugs to provide the desired effect (Page 44). Because the concentration of ciprofloxacin taught by Suhaeri was not found to be toxic to wound-infected mice, and the concentration of sodium chlorate taught by Spero did not result in accumulation of toxic by-product in neighboring cells, the amounts taught by the prior art are nontoxic but sufficient to provide the desired antibacterial and wound healing effects.
Applicant lastly argues that the demonstrated effectiveness of chlorate would at least be unexpected in view of the cited documents, noting that the described mechanism of action includes biofilm disruption, infection control, and promotion of regeneration through coordinated cellular and extracellular matrix remodeling. This argument was found unpersuasive both in absence of any data comparing Applicant’s instant invention to the closest prior art and in view of the references relied upon in the prior art rejections above, which teach all features of the proposed wound healing mechanism as discussed in detail above. Note: MPEP: 716.02(b)(I). Regarding alleged unexpected results, the evidence relied upon should establish "that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance." Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992) (Mere conclusions in appellants’ brief that the claimed polymer had an unexpectedly increased impact strength "are not entitled to the weight of conclusions accompanying the evidence, either in the specification or in a declaration.").
In view of the foregoing, the prior art rejections above are maintained.
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 § 2146 et seq. 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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claims 1-4, 6-15, 17-20, and 41 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 5-6, 12-16, 19-20, 25-29, and 31 and of copending Application No. 16/157885 in view of Spero et al. 2018 (IDS of 09/08/2021), Suhaeri et al. 2018 (PTO-892 of 02/12/2025), Chen et al. 2016 (CN106344955A; PTO-892 of 04/20/2023), and Danner 1995 (US5855922A; PTO-892 of 04/20/2023).
App. ‘885 claims 1, 12, and 31 are drawn to methods for reducing antibiotic resistance and/or survivability and treating and/or preventing bacterial infections of Nar-containing bacteria. App. ‘885 claim 19 is drawn to an antimicrobial suitable to reduce resistance and/or survivability of Nar-containing bacteria. App. ‘885 claims 20 and 21 are drawn to systems for reducing survivability and/or antibiotic resistance and treating and/or preventing bacterial infections of Nar-containing bacteria.
The claims of App. ‘885 differ from the instant claims in that they do not explicitly recite the limitations drawn to wound healing, chronic wounds, or wound healing agents related to the compositions and/or methods of instant claims 1, 11, 18, and 41. The claims of App. ‘885 also do not recite the limitations of instant claim 7-10, 17, or 19-20.
The teachings of Spero, Suhaeri, Chen, and Danner are as set forth above (see Claim Rejections - 35 USC § 103).
Regarding instant claim 1, it would have been obvious to one of ordinary skill in the art to use the effective amount of chlorate, alone or in combination with an antibiotic and/or other antimicrobial recited in the claims of App. ‘885 as a wound healing composition for treating and/or preventing bacterial infection in a chronic wound. One of ordinary skill would have been motivated and there is a reasonable expectation of success because Spero teaches that sodium chlorate is known to combat antibiotic resistance and effectively kill P. aeruginosa bacteria in biofilms like those found in chronic infections.
Regarding instant claims 7, 8, 11, 18, and 41, it would have been obvious to one of ordinary skill in the art to deliver the chlorate recited in the claims of App. ‘885 using the PVA/Cipro/hFDM skin wound patch taught by Suhaeri to create a biofilm treatment matrix. One of ordinary skill in the art would have been motivated to embed chlorate in the PVA/Cipro/hFDM skin wound patch as a hydrogel delivery matrix because the patch is known to effectively kill a wide range of gram-negative and -positive bacteria and to promote enhanced wound regeneration, and the sodium chlorate, particularly when used in combination with an antibiotic, is known to combat antibiotic resistance and effectively kill P. aeruginosa bacteria in biofilms like those found in chronic infections. There is a reasonable expectation of success in producing a biofilm treatment matrix capable of treating a bacterial infection in a wound by contacting the wound because Suhaeri teaches the application of the skin wound patch to the infected skin wound of a mouse to promote enhanced wound regeneration.
Regarding instant claims 9, 10, and 17, it would have been obvious one of ordinary skill in the art to modify the wound healing composition embedded in a skin wound patch taught by the combination of App. ‘885 claims, Spero, and Suhaeri by adding the EGF and vitamin E wound repair agents taught by Chen. One of ordinary skill would have been motivated to add EGF and vitamin E to the wound healing composition because Chen teaches that such agents are useful for repairing skin staining and other skin problems, such as chloasma, that can occur at the site of skin wounds. Further, Suhaeri teaches that wounds recover structural integrity and function via interactions among cells, growth factors, and ECM, suggesting that the presence of additional growth factors like EGF, which contributes to synthesis and secretion of ECM, would be beneficial in promoting wound healing. There is a reasonable expectation of success because Chen teaches the use of compositions comprising EGF and vitamin E in polymer-based skin wound dressings, which is akin to the PVA/hFDM-based skin wound patch taught by the combination of App. ‘885 claims, Spero, and Suhaeri.
Regarding instant claim 19, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to administer a therapeutically effective amount of chlorite to the wound prior to contacting the wound with the wound healing composition taught by the combination of Suhaeri, Spero, and Walters. One of ordinary skill in the art would have been motivated to first add chlorite to the wound because Danner teaches that sodium chlorite antiseptic compositions have low levels of irritation and toxicity, promote quicker healing and reduced scarring, and are preferably applied as soon as possible after infection appears. There is a reasonable expectation of success because Danner teaches the use of the composition in treating dermal wounds and dermal infection, as well as for prophylactic prevention of decubitus wounds.
Regarding instant claim 20, it would have been obvious to one of ordinary skill in the art to apply the wound healing agents EFG and vitamin E, as taught by Chen, to the wound after contacting the wound with the wound healing composition embedded within a biofilm treatment matrix taught by the combination of App. ‘885 claims, Spero, Suhaeri, and Chen. One of ordinary skill would have been motivated to apply the agents subsequently because Chen teaches that such agents are useful for repairing skin staining and other skin problems, such as chloasma, that can occur at the site of skin wounds and, importantly, Suhaeri teaches that upon degradation of hFDM, bioactivity of its growth factors would be significantly compromised, suggesting that the presence of additional growth factors like EGF, which contributes to synthesis and secretion of ECM, would be beneficial in promoting wound healing. There is a reasonable expectation of success because Chen teaches the use of compositions comprising EGF and vitamin E for repairing skin wounds.
Response to Arguments
Applicant’s arguments submitted on 08/12/2025 with respect to rejections on the grounds of non-statutory double patenting have been fully considered but are not found to be persuasive.
Applicant argues that the non-statutory double patenting rejections should be withdrawn in view of the same evidence and arguments applied to the prior art rejections above. This argument is unpersuasive for the same reasons as discussed in the Response to Arguments section above with respect to rejections under 35 U.S.C. 103.
Applicant further references MPEP 804(II)(B)(1), which states that the disclosure of the copending application may not be used when considering whether the instantly claimed invention would be an obvious variation of the invention defined in the copending claims. While Applicant does not appear to indicate how this provision applies to the Examiner’s rejection of record, the Examiner notes that all motivations relied upon for modification of the invention defined in the copending claims were derived from the prior art of record, as discussed in detail in the non-statutory double patenting rejections above.
Therefore, Applicant’s arguments were not found to be persuasive, and the rejections are maintained.
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/SARAH C WISTNER/Examiner, Art Unit 1616
/SUE X LIU/Supervisory Patent Examiner, Art Unit 1616