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 .
Summary
Receipt of Applicant’s Preliminary/Remarks and Amendments filed on 08/09/2024 is acknowledged. Claims 1-17 are pending. Claims 5-14 and 17 stand currently amended. Claims 1-4, 11, 15 and 16 stand as originally filed.
Claims 1-17 are pending and under examination in this application.
Priority
The current application filed on 08/09/2024 is a 371 of PCT/EP2023/053228 filed 02/09/2023, which in turn claims priority to patent application DE102022103062.8 filed on 02/09/2022.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 08/09/2024 and 12/17/2024 are in compliance with the provisions of 37 CFR 1.98. Accordingly, the information disclosure statements has been considered by the examiner. Signed copies have been attached to this office action.
Claim Objections
Claim 17 is objected to because of the following informalities: The amendment strikes “in claims 5 to 13” and inserts “active ingredient,” but leaves the claim reciting “the agent is characterized as active ingredient,” which lacks an object and does not particularly identify what the agent is characterized as an active ingredient of. Moreover, compare claim 14, correctly amended to “characterized as in claim 5.” Applicant is invited to amend claim 17 in parallel fashion (e.g., “characterized as in claim 5”).. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claim 17 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 17 as amended, “the agent is characterized as active ingredient” is grammatically incomplete and fails to identify the referenced limitation, rendering the scope of the claim indeterminate. For purposes of applying prior art below, claim 17 is treated as depending from claim 16 and incorporating the limitations of claim 5 (colestyramine and/or colesevelam as active ingredient), by analogy to the parallel, properly-amended claim 14.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
The following art is applied. Each reference qualifies as prior art under
§ 102(a)(1); none require analysis of any exception under § 102(b), as each publication date precedes the 09 February 2022 priority date by a period ranging from approximately 2 to 30 years.
• Seidel WO 2012/123363 A1, published 20 September 2012
• Capelli US 2004/0223944 A1, published 11 November 2004
• Yamazaki US 5,098,417 A, published 24 March 1992
• Lanham et al., “Outpatient Burn Care: Prevention and Treatment,” Am Fam Physician, 2020 Apr 15;101(8):463–470 (hereinafter “Lanham”)
• Black et al.; National Pressure Ulcer Advisory Panel, “National Pressure Ulcer Advisory Panel’s Updated Pressure Ulcer Staging System,” Dermatology Nursing, 2007 Aug;19(4):343–349 (hereinafter “Black”)
Rejection 1 — Claims 1, 3, 5–12,16, and 17 are rejected under 35 U.S.C. § 102(a)(1) as being anticipated by Seidel (WO 2012/123363 A1).
Seidel discloses a material for treating local bacterial infections and to the use of this material in wound management (abstract).
Regarding claim 1, Seidel discloses a material for treating local bacterial infections and its use in wound management ([0001]), for the prevention and/or treatment of harmful effects of local bacterial infections or critical colonizations in the wound or lesion area ([0016]). Seidel discloses that the material comprises, as active ingredient, an anion exchanger — including cholestyramine — capable of adsorbing/binding bacterial lipopolysaccharide (LPS) and lipoteichoic acid (LTA), thereby biologically neutralizing these toxins ([0018]–[0019]: “it is possible to bring about a considerable improvement in the pathophysiological circumstances in the region of the wound”; Example, [0064]: colestyramine achieving approximately 95% LPS and 95% LTA elimination from simulated wound exudate while removing only 5–10% of TNF-α and IL-6).
Regarding claim 3 (chronic wound / in particular ulcus cruris): Seidel discloses treatment of chronic wounds as the central problem addressed by the invention ([0008]–[0009]). The “in particular” language of claim 3 is non-limiting exemplary language; the base limitation, “chronic wound,” is fully disclosed.
Regarding claim 5 (colestyramine and/or colesevelam as active ingredient): Seidel explicitly names cholestyramine (poly(trimethylammoniomethylstyrene chloride-co-divinylbenzene)) as an exemplary anion-exchanger moiety bearing the preferred trimethylbenzylammonium exchange group ([0043]).
Regarding claims 6–7 (galenical form; direct application, or placement in a moisture-/liquid-permeable container or on a moisture-/liquid-impermeable film/support): Seidel discloses presentation as foams, hydrogels, hydrofibers, hydrocolloids, and alginates ([0025]), and direct introduction of the material into the wound or infection cavity, including as a drainage material removable without renewed operative intervention ([0017], [0027]).
Regarding claim 8 (integrated into conventional wound dressing): Seidel discloses combining the anion-exchanger material as an additional or mixed layer with known wound dressing materials ([0047]).
Regarding claim 9 (active ingredient incorporated into a matrix forming an adhesive layer on the wound or skin): Seidel’s single-layer embodiment discloses the anion exchanger incorporated directly into the wound-contacting layer, which is placed and held against the wound or skin surface ([0045]–[0046]).
Regarding claim 10 (in addition to the anion exchanger, includes one or more further active ingredients in combination): Seidel discloses that its material can be used in combination with antibiotics or other bactericidal active ingredients ([0050]), satisfying this limitation.
Regarding claim 11 (further active ingredient selected from the recited Markush group, including antibiotics): Seidel’s disclosure of combination with “antibiotics” ([0050]) anticipates this claim; disclosure of a single recited species (antibiotics) is sufficient to anticipate a Markush-type limitation.
Regarding claim 12 (wound/lesion type — superficial or deep wound, open infected acute or chronic wound, subcutaneous infection, deep-seated infected region optionally after implantation of a foreign object, efflorescence of the skin, burn, folliculitis, boil, acne, dermatitis, neurodermatitis, or decubitus): This is an alternative (Markush-type) limitation; disclosure of any one recited alternative anticipates the claim. Seidel discloses “superficial or deep” wounds and “burns” directly ([0011], [0025]/[0027] context), satisfying the claim.
Regarding claims 16–17 (method claim mirroring claim 1, with claim 17 construed per the § 112(b) rejection above as incorporating claim 5’s colestyramine limitation): Anticipated on the same basis as claims 1 and 5, respectively.
Rejection 2 — Claims 14 and 15 are rejected under 35 U.S.C. § 102(a)(1) as being anticipated by Yamazaki (US 5,098,417 A).
Yamazaki discloses a wound dressing comprising a cellulosic substrate chemically modified to anion-exchange (dialkylaminoalkyl, e.g., diethylaminoethyl (DEAE)) sites (Claims 1–4), and explicitly states: “The wound dressings of this invention can also be used to treat skin diseases, e.g., acne, or inflammation. They may also find the same applications as cosmetics…” (Description, following Example 3 discussion of enzyme-adsorbing dressings). Yamazaki’s anion-exchange cloth functions primarily as an ion-exchange carrier for separately-loaded anionic drugs (fusidic acid, antifungals, etc.), released by ion exchange with wound-fluid ions; Yamazaki does not disclose the anion exchanger itself binding/neutralizing bacterial toxins as the operative mechanism. Yamazaki is accordingly relied upon here only for claims 14–15, which do not recite that mechanism, and is not asserted as anticipatory of claim 1’s mechanism limitation.
Regarding claim 14 (non-therapeutic use of agent containing an anion exchanger for cosmetic purposes): the “characterized as in claim 5” language is non-limiting “preferably” language and need not be met for anticipation of the base claim): Yamazaki discloses a wound dressing comprising a cellulosic substrate modified with anion-exchange (diethylaminoethyl) groups, and expressly states the dressings “can also be used to treat skin diseases, e.g., acne, or inflammation,” and “may also find the same applications as cosmetics” (col. 15, ll. 36–68).
Regarding claim 15 (treatment/prophylaxis of mild-to-moderate acne, pimples, pustules, blackheads): Yamazaki’s explicit disclosure of acne treatment anticipates this claim. (col. 15, lines 36–68).
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.
Rejection 3 — Claims 2 and 4 are rejected under 35 U.S.C. § 103 as being unpatentable over Seidel (WO 2012/123363 A1) in view of Capelli (US 2004/0223944 A1), and further in view of Lanham and Black as evidence of the well-known state of the art regarding wound-severity classification.
Seidel establishes that anion-exchange materials generally — including cholestyramine specifically, and by extension other anion-exchange resins bearing trimethylbenzylammonium, diethylaminoethyl, or equivalent cationic functional groups — are suited to LPS/LTA adsorption in a wound-care context, combinable with antibiotics without antagonism (Seidel, Description: “materials according to the invention can also be used in combination with antibiotics or other bactericidal active ingredients”).
Capelli discloses cholestyramine resin, as a wound-dressing component (hydrocolloids, gauzes, foams, xerogels), loaded with an antimicrobial silver complex (Capelli, Claims 1–3; Description).
Regarding claim 2 (burn of at least grade 2, in particular grade 2 or 2b) and Claim 4 (decubitus of at least grade 2 or grade 3): Seidel discloses treatment of “burns” as one of the wound types addressed by the claimed material ([0011]), and Capelli separately discloses that its anion-exchanger wound-care compositions are used to treat, among other conditions, burns and “bed sores… pressure sores” (i.e., decubitus) ([0032]). Neither reference specifies a numerical grade or stage for these conditions. However, standardized clinical classification systems for burn depth (superficial/first-degree, superficial and deep partial-thickness/second-degree, and full-thickness/third-degree, per American Burn Association convention, as set forth in (Lanham, Am Fam Physician 2020;101(8):463–470, at 464: “The American Burn Association classifies burns by depth: superficial (first-degree), partial-thickness (second-degree)…and full-thickness (third-degree)”)) and for decubitus/pressure-ulcer severity (Stage I–IV, per the National Pressure Ulcer Advisory Panel’s staging system, as set forth in (Black, Dermatology Nursing 2007;19(4):343–349)) were well-established and universally used in the art well before the priority date of the instant application, as documented in Lanham and Black. It would have been obvious to a person of ordinary skill in the art to apply Seidel’s disclosed anion-exchanger material to burns or decubitus ulcers of any specific, art-recognized grade or stage, including grade 2, 2b, or 3, because grading and staging are routine descriptive classifications of the wound population being treated, not technical modifications of the claimed composition or method — a practitioner treating “burns” or “decubitus” per Seidel/Capelli would necessarily be treating wounds falling within one or another of these standard, well-known grades as a matter of course.
Rejection 4 — Claim 13 is rejected under 35 U.S.C. § 103 as being unpatentable over (Seidel).
Regrading claim 13 (prophylactic application for a genetic disposition, or a disposition to neurodermatitis, burns, or decubitus, to prevent critical colonization or bacterial infection): Seidel discloses prophylactic, immediate application of its LPS/LTA-binding material after surgery, before an infection is established, precisely to prevent critical colonization ([0017]: “isolated as an immediate treatment after surgery”). It would have been obvious to extend this same prophylactic-use teaching to patients recognized as being at elevated risk for critical colonization or bacterial infection — including those with a disposition to burns, decubitus, or neurodermatitis (all conditions Seidel’s material is already disclosed to treat therapeutically) — as a routine, foreseeable extension of Seidel’s own prophylactic embodiment to known at-risk populations, with a reasonable expectation of success given the material’s already-disclosed mechanism of action.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDRE MACH whose telephone number is (571)272-2755. The examiner can normally be reached 0800 - 1700 M-F.
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/ANDRE MACH/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
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