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 .
Information Disclosure Statements
Information Disclosure Statement (IDS) filed on 01/13/2026 has been considered by the Examiner. A signed copy of the IDS is included with the present Office Action.
Status of the Claims
Applicants' arguments and amendments filed on 02/24/2026 have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claims 1, 4-7 and 17 are under current examination The elected specie are wherein the structure of the substrate is gel forming fibers with a coating of a bacteriostatic composition that contains deferiprone, HPMC (claim 6) and ethanol (claims 5 and 7).
Maintained Rejections
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 are rejected under 35 U.S.C. 103 as being unpatentable over Carlsson et al. (United States Patent Publication 2017/0021050) in view of Patel et al. (US20070255192) in view of Vreugde et al. (WO2017035582-see IDS filed on 09/26/2023).
Claim 1 is to a medical dressing comprising a substrate, wherein said dressing comprises a bacteriostatic composition; said bacteriostatic composition being integrated in said substrate and/or provided as a coating on at least a portion of a surface of said substrate, characterized in that said bacteriostatic composition comprises deferiprone. The instant claims are under current examination as directed to the elected species: wherein the structure of the substrate is gel forming fibers, wherein the coating comprises HPMC and ethanol and deferiprone is the specific active present as the bacteriostatic composition.
Carlsson et al. teach antimicrobial wound dressing substates which comprise cross-linked absorbent gelling fibers, see paragraph [0023]. The absorbent fibers can comprise polyvinyl alcohol (PVA) see paragraph [0023]. The wound dressing substrates comprise an antimicrobial coating composition associated with at least a portion of the surface wherein the coating contains hydroxypropylmethylcelluose (HPMC), see claims 9, 30 and paragraphs [0003]-[0004] and [0037] and [0056]. According to Carlsson, the antimicrobial coating can be on both sides of the dressing and thus contacts a wound surface, see paragraphs [0059]-[0060]. Examples of active agents in the coating include polyhexamethylenebiguanide (PHMB), see paragraphs [0004], and [0029]. The coating comprises non-aqueous solvent comprising ethanol, see claims 1 and 17, and paragraphs [0043] and [0058].
Carlsson et al. do not expressly teach the presence of deferiprone in the antimicrobial coating composition for the absorbent PVA gelling fibers or that the coating can be bacteriostatic.
However, Patel et al. teach wound dressings which comprise coatings of an antimicrobial agent and chelating agent, see paragraphs [0018] and [0007]. Suitable antimicrobial agents include polyhexamethylene biguanide or silver, see paragraphs [0023] and [0025]. Any suitable chelating agent may be utilized, see paragraph [0024]. Patel et al. teach that chelating agents heighten the susceptibility to bacteria an other organisms to the effects of the anti-microbial agent rendering the wound dressing more effective in combatting or preventing infection, see paragraph [0024]. Together the chelating agent and antimicrobials provide synergistic benefit, see paragraph [0032]. The dressings can include further active agents that provide bacteriostatic activity, see claim 17.
Patel et al. do not expressly teach deferiprone as the specific chelating agent.
Vreugde et al. teach prevention of bacterial infections caused by bacteria by administering a composition which comprise deferiprone, see paragraphs [0003], [0011]-[0029], [0021]-[0025] and [0058]-[0063]. Deferiprone is taught as an iron chelator which triggers iron depravation of S. aureus and has antimicrobial activity due to the result of ion chelation and nutrient deprivation, see paragraphs [0368]-[0370]. The composition can treat bacteria by topical application, see paragraphs [0021]-[0026], [0139] and [0257].
It would have been prima facie obvious to provide the antimicrobial coating of Carlsson et al. with the chelating agent of deferiprone.
One of ordinary skill in the art would have been motivated to do so because Patel et al. teaches that chelating agents heighten the susceptibility to bacteria to the effects of the anti-microbial agents rendering the wound dressing more effective in combatting or preventing infection, and Vreugde et al. recognizes that deferiprone is an effective chelating agent with antimicrobial activity for compositions that can prevent bacterial infection.
There would have been a reasonable expectation of success because Carlsson et al. teaches wound dressings having an antimicrobial coating comprising PHMB and Patel teaches that PHMB antimicrobials with any suitable chelating agent are more effective in combatting or preventing infection. Per the teachings of Vreugde et al., deferiprone is recognized as a suitable chelating agent which deprives bacteria of nutrients.
Since the modified Carlsson et al. teach a coatings comprising deferiprone chelator with HPMC and ethanol in which the active agents comprising deferiprone are useful in prevention of bacterial infections, the coating composition of the modified Carlsson et al. is considered bacteriostatic. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). Furthermore, per the instant specification at page 10, bacteriostatic is inclusive of a composition that prevents growth of bacteria. Both Patel et al. and Vreugde et al. teach prevention of bacterial infections with compositions that contain chelating agents.
Accordingly, the instant claims are rendered prima facie obvious over the teachings of Carlsson et al., Patel et al. and Vreugde et al.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Carlsson et al. (United States Patent Publication 2017/0021050) in view of Patel et al. (US20070255192) in view of Vreugde et al. (WO2017035582-see IDS filed on 09/26/2023) as applied to claims 1, and 4-6 above, and further in view of Mohammadpour et al. (Wound Healing by topical application of antioxidant iron chelators: kojic acid and deferiprone).
Regarding instant claim 7, Carlsson et al. tech that the one or more polymers inclusive of HPMC can be less than 20% by weight inclusive of a range of 0-20% by weight, see paragraphs [0037] and [0040]. Water can comprise from 1-10% by weight, see paragraph [0045]. Water can also be optional because in some embodiments water can comprise less than 1% water which is a range inclusive of 0% by weight, see paragraph [0035]. The antimicrobial coating contains a non-aqueous solvent system inclusive of ethanol, see paragraph [0034]. According to example 1, the amount of ethanol can be about 69.979% by weight since ethanol is added at an amount of 100g per total components of 142.9g (100g ethanol, together with 3.6g of silver sulfate, 35 grams water, and 4.3g HPMC), see example 1 at paragraph [0101]. With water this is about 69.979%. However, in embodiments where water is not present (i.e. minus the 35 grams of example 1), the amount is 92.678% ethanol. Accordingly, the amounts of ethanol and HPMC suggested by Carlsson overlap and render obvious the instantly claimed ranges of claim 7. Per MPEP 2144.05, In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). The deferiprone of the modified Carlsson is taught at 50mM or in alternative embodiments anything greater than 10mM, see paragraph [0142], however a weight percent of deferiprone is not disclosed.
Neither Carlsson et al., Patel et al. nor Vreugde et al. teach the amount by weight of deferiprone present for the coated wound dressing.
However, Mohammadpour et al. teach that topical treatment with 3% and 6% by weight deferiprone demonstrates accelerated wound healing properties, see abstract, methods and Table 2. Deferiprone showed beneficial effects in accelerating wound healing which can be attributed to its antioxidant, iron chelating, and antimicrobial capabilities, see discussion section.
It would have been prima facie obvious to provide the modified Carlsson et al. with 3% or 6% by weight of deferiprone.
One of ordinary skill in the art would have been motivated to do so as per the teachings of Mohammadpour et al., these amounts demonstrate accelerated wound healing properties for topical treatment of deferiprone.
There would have been a reasonable expectation of success given both the modified Carlsson and Mohammadpour teach topically treating wounds.
Response to Remarks
Applicants argue that there is nothing in Patel that discloses that deferiprone is combined with PHMB. Nothing in Vreugde discloses deferiprone with PHMB.
Examiner respectfully submits that Patel et al. teach that chelating agents heighten the susceptibility to bacteria an other organisms to the effects of the anti-microbial agent rendering the wound dressing more effective in combatting or preventing infection, see paragraph [0024] and Patel teaches such actives like Carlsson include PHMB. Vreugde et al. teach prevention of bacterial infections caused by bacteria by administering a composition which comprise deferiprone, see paragraphs [0003], [0011]-[0029], [0021]-[0025] and [0058]-[0063]. Deferiprone is taught as an iron chelator which triggers iron depravation of S. aureus and has antimicrobial activity due to the result of ion chelation and nutrient deprivation, see paragraphs [0368]-[0370]. The composition can treat bacteria by topical application, see paragraphs [0021]-[0026], [0139] and [0257]. Thus, Vreugde establishes that deferiprone is an effective antimicrobial chelator. One of ordinary skill in the art would have been motivated to include deferiprone with Carlsson’s PHMB because Patel et al. teaches that chelating agents heighten the susceptibility to bacteria to the effects of the anti-microbial agents rendering the wound dressing more effective in combatting or preventing infection, and Vreugde et al. recognizes that deferiprone is an effective chelating agent with antimicrobial activity for compositions that can prevent bacterial infection. There would have been a reasonable expectation of success because Carlsson et al. teaches wound dressings having an antimicrobial coating comprising PHMB and Patel teaches that PHMB antimicrobials with any suitable chelating agent are more effective in combatting or preventing infection. Per the teachings of Vreugde et al., deferiprone is recognized as a suitable chelating agent which deprives bacteria of nutrients. The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). Here, the combined teachings demonstrate that chelators help heighten sensitivity to bacteria to antimicrobial agents per the teachings of Vreugde, deferiprone is a known chelator with antimicrobial property. Thus one of ordinary skill in the art would have been motivated to combine the PHMB of Carlsson with a chelator such as deferiprone to achieve enhanced antimicrobial activity.
Regarding new claim 17 which recites deferiprone is the only active Applicants argue this amendment excludes other active substances including PHMB taught by Carlsson.
Examiner respectfully submits that new claim 17 is addressed in the new grounds of rejection which do not rely on the teachings of Carlsson.
New Rejections necessitated by addition of new claim 17
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 1 is to a medical dressing comprising a substrate, wherein said dressing comprises a bacteriostatic composition; said bacteriostatic composition being integrated in said substrate and/or provided as a coating on at least a portion of a surface of said substrate, characterized in that said bacteriostatic composition comprises deferiprone. The instant claims are under current examination as directed to the elected species: wherein the structure of the substrate is gel forming fibers, wherein the coating comprises HPMC and ethanol and deferiprone is the specific active present as the bacteriostatic composition. Claim 17 limits claim 1 in that deferiprone is the only active ingredient present.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Gurtner et al. (United States Patent Publication 20100092546-see IDS filed on 9/26/2023) in view of Schmitz et al. (United States Patent Publication 20130323195).
Gurtner et al. teach compositions which deliver actives such as deferiprone alone, see abstract. The composition can comprise a carrier for the active which is applied to a wound dressing to administer to skin, thus suggesting the active must be in contact with a wound surface see paragraph [0039]. Medical dressings can be fibrous and may comprise a gel that absorbs or have disposed thereon (i.e. coating) a therapeutic composition, see paragraph [0056]. The medical dressings contact wound with a therapeutic composition thus indicating that the skin wound is in contact with a therapeutic composition, see paragraph [0056]. The wounds ban be treated with just deferiprone, see paragraph [00012] and claims 1 and 4.
Gurtner does not expressly teach a fibrous gel of polyvinyl alcohol for the dressing.
Schmitz et al. teach that wound dressings which include hydrogelling fibers provide improved wound care and high stability, see paragraphs [0009] [0067]-[0068] . Polyvinyl alcohol provides high biocompatibility and stability, see paragraph [0005]. Hydrogelling fibers are applied in a dry state to the wound and they form stable gels with the wound exudate, thus creating a moist wound climate. Such a moist wound treatment may assist the healing process, see paragraph [0017].
It would have been prima facie obvious to provide the wound dressing of Gurtner as hydrogelling polyvinyl alcohol fibers.
One of ordinary skill in the art would have been motivated to do so because hydrogelling fibers are taught to for stable gels which assist with wound healing and polyvinyl alcohol provides increased biocompatibility for the wound dressing.
There would have been a reasonable expectation of success because both Gurtner and Schmitz teach wound dressings.
Conclusion
Applicant’s arguments/remarks are considered unpersuasive and new claim 17 necessitated a new grounds of rejection. Accordingly, 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).
Currently, claims 1, 4-7 and 17 are rejected and no claims are allowed.
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 extension fee 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.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH ALAWADI whose telephone number is (571)270-7678. The examiner can normally be reached Monday-Friday 10:00am-6:30pm 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, David Blanchard can be reached at 571-272-0827. 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.
/SARAH ALAWADI/Primary Examiner, Art Unit 1619
Prosecution Insights