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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-29, 34 and 35 in the reply filed on December 17, 2025 is acknowledged. Accordingly claim s 30-33 have been withdrawn.
Information Disclosure Statement
The information disclosure statements filed June 6, 2023 and April 5, 2025 have been received and made of record. Note the acknowledged PTO-1449 form enclosed herewith.
Specification
The disclosure is objected to because of the following informalities: para. [0010] includes claims 1, 16, 22, 23, 24, 26 and 27 numbers; however, the claim numbering may change upon allowance therefore Applicants are advised to remove the reference to the claims in para. [0010]. 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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 13, 16, 34 and 35 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 13, “the skin” in line 4 lacks proper antecedent basis.
Regarding claim 16, “the propellant” in line 1 lack proper antecedent basis. This claim is being interpreted as depending from claim 3.
Regarding claims 34 and 35, the claim is indefinite in that the Office is unclear as to whether Applicant’s are claim a method claim since there are no method steps. The claims will be interpreted as an intended use claims.
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.
Claim(s) 1, 2, 14, 15, 20, and 21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by DE 4229924 A1 translation (“Juergen”).
Regarding claim 1, Juergens discloses plaster preparations (for topical treatment of human or animal skin, see page 1, lines 4-11, comprising: a) at least one resorbable polymer made of at least 3 monomer units, being a terpolymer, comprising monomers selected from the group consisting of: trimethylene carbonate; glycolide; lactide; p-dioxanone; Ɛ-caprolactone and/or butyrolactone (note the use racemic lactide, Ɛ-caprolactone and glycolide on page 2, lines 3-4) ; and b) at least one readily vaporizable organic solvent (note the disclosure of acetone, for example, on page 2, lines 2-8; acetone is highly vaporizable).
Regarding claim 2, Juergens discloses the plaster preparation according to claim 1, wherein the lactide is D, L-lactide (Juergens discloses the use of racemic lactide which is an equimolar mixture of L-lactide and D-lactide).
Regarding claim 14, Juergens discloses the plaster preparation according to claim 1, wherein the organic solvent is selected from the group consisting of acetone, methyl acetate, ethyl acetate, halogenated hydrocarbons, DMSO, N-pyrrolidone, cyclopentane and/or mixtures thereof with cyclopentane (note the disclosure of acetone, for example, on page 2, lines 2-8; acetone is highly vaporizable).
Regarding claim 15, Juergens discloses the plaster preparation according to claim 1, wherein the terpolymer present is dissolved in the organic solvent (note page 2, lines 6-7 recites “[t]o produce sprays, the copolymers are used in the amount simply dissolved in a suitable solvent and can then be sprayed as an aerosol”).
Regarding claim 20, Juergens discloses the plaster preparation according to claim 1, wherein the plaster preparation additionally contains UVA and/or UVB filters, cytokines, growth factors being TGF-B, local anesthetics, hemostatic or antibacterial active substances and/or biologically inactive additives being dyes or cyanoacrylates (note the disclosure of the addition of antibiotics, which are antibacterial, on page 2, lines 22-24).
Regarding claim 21, Juergens discloses a polymer film produced by means of applying or spraying of the plaster preparation according to claim 1 (note the disclosure of producing films on page 2, lines 11-15).
Claim(s) 1, 4, 12, 13, 34 and 35 are is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2015189389 A1 (“Hierlemann”).
Regarding claim 1, Hierlemann discloses wound contact material for use in the treatment and/or care of wounds. More specifically, Helmut discloses a plaster preparation, comprising: a) at least one resorbable polymer made of at least 3 monomer units, being a terpolymer, comprising monomers selected from the group consisting of: trimethylene carbonate; glycolide; lactide; p-dioxanone ;Ɛ-caprolactone and/or butyrolactone (note the disclosure of use of DL- lactide, Ɛ-caprolactone and trimethylene carbonate being used to prepare the wound contact material, see page 7, lines 33-39); and b) at least one readily vaporizable organic solvent (note the disclosure of 1,4-dioxane, an organic solvent on page 7, lines 40-41).
Regarding claim 4, Hierlemann discloses thee plaster preparation according to claim 1, wherein the resorbable polymer consists of: lactide being D,L-lactide, E-caprolactone and trimethylene carbonate (note the rejection of claim 1 above).
Regarding claim 12, Hierlemann discloses the plaster preparation according to claim 1, additionally comprising: at least one further resorbable polymer from the group consisting of poly-s- caprolactone, polylactide, polyglycolide, polyethylene glycol and poloxamer; and/or at least one non-resorbable polymer from the group consisting of polyacrylates, polycyanoacrylates, and polyurethanes; wherein the non-resorbable polymers are admixed as a blend (note the disclosure of a further polymer, such as polyurethane on page 2, lines 7-10).
Regarding claim 13, Hierlemann discloses the plaster preparation according to claim 1, additionally comprising: at least one further resorbable polymer from the group consisting of poly-E- caprolactone, polylactide, polyglycolide and polyethylene glycol; and/or at least one monomer, being cyanoacrylate, which polymerizes out on the skin to a non-resorbable polymer and yields a polymer blend of a resorbable polymer and a non-resorbable polymer (note the disclosure of a further polymer, such as polylactide on page 2, lines 5-6).
Regarding claim 34, Hierlemann disclose the use of the plaster preparation (wound contact material) according to claim 1 for topical treating of human or animal skin for wound treatment of epidermal and dermal wounds being abrasions, cuts, burn wounds, chronic wounds and ulcer wounds (see page 6, lines 8-12 which recite “the wound to be treated or treated is preferably a chronic wound or a traumatic wound. The chronic wound may be selected from the group consisting of pressure-induced ulcer (decubital ulcer), arterial ulcer, venous ulcer, mixed arterial-venous ulcer, ulcer cruris, arterial ulcer cruris, venous ulcer cruris, ulcer in diabetic foot syndrome and posttraumatic ulcer”.
Regarding claim 35, Hierlemann discloses a plaster preparation according to claim 1, which is fully capable of external application to a user in the case of reddening of the skin, sunburn, sun protection, cosmetic applications, camouflage and/or as a resorbable adhesive.
Claim(s) 1, 6, 21 and 26 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent No. 2002/0028231 (“Hierlemann et al.)”.
Regarding claim 1, Hierlemann discloses resorbable, synthetic, medical coating material, method for its manufacture and its use in medicine. More specifically, Hierlemann et al. discloses a plaster preparation, comprising: a) at least one resorbable polymer made of at least 3 monomer units, being a terpolymer, comprising monomers selected from the group consisting of: trimethylene carbonate; glycolide; lactide; p-dioxanone; Ɛ-caprolactone and/or butyrolactone (note the disclosure of use of lactide (para. [0009]), Ɛ-caprolactone and trimethylene carbonate being used to prepare a wound contact material, see the abstract); and b) at least one readily vaporizable organic solvent (note the disclosure of organic solvents such as ethyl acetate, acetone, etc. in para. [0029] on page 7, lines 40-41).
Regarding claim 6, Hierlemann et al. discloses the plaster preparation according to claim 1, wherein the resorbable polymer consists of 70 to 85% w/w D,L-lactide, 5 to 20% w/w epsilon-caprolactone and 5 to 20% w/w trimethylene carbonate ).
Regarding claim 21, Hierlemann et al. discloses a polymer film produced by means of applying or spraying of the plaster preparation according to claim 1 (note the disclosure of both spraying a liquid form in para. [0027], which will form a film).
Regarding claim 26, Hierlemann et al. discloses the polymer film according to claim 21, wherein the polymer film has an extensibility between 250 and 600% (note the disclosure of an extensibility of 250% in para. [0015].
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.
Claim(s) 3 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Juergens in view JP H067423 A (“Teiputon”).
Regarding claim 3, Juergens discloses the plaster preparation according to claim 1, wherein the plaster preparation is a spray plaster preparation, but does not explicitly disclose the plaster preparation is a spray plaster preparation with at least one propellant.
However, Teiputon in the disclosure of an analogous spray plaster preparation for coating on human or animal tissue, teaches spray administration means consists of at least one propellant, wherein the propellant is a liquefied and compressed gas and has the action of dispensing the liquid composition from the pressure vessel by movement of the valve of the dosing means. Liquid compositions are administered as a wet spray, fine spray, or foam, depending on the type of propellant (page 11, lines 27-30). Teiputon also teaches the use compressed gas, for example, such as carbon dioxide, nitrous oxide, nitrogen and the like because they are non-toxic, non-inflammatory and inert (page 12, lines 5-6).
In view of Teiputon, it would have been obvious to one having ordinary skill in the art before the effective filing date of the presently claimed invention to have used a compressed gas propellant, for example, carbon dioxide, to assist in dispensing the preparation of Juergen in order to administer the preparation as a wet spray, fine spray. The selection of carbon dioxide would have been obvious since it is widely available.
Regarding claim 16, modified Juergen discloses the plaster preparation according to claim 1 (interpreted as 3), wherein the propellant is dimethyl ether, methane, propane, butane, pentane, butene, low-boiling halogenated hydrocarbons, noble gases, air and/or CO2 (note the rejection of claim 3 above).
Claim(s) 5, 7-11, 17, 18, 22-25 and 27-29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hierlemann et al.
Regarding claim 5, Hierlemann et al. discloses the plaster preparation according to claim 1, wherein the resorbable polymer consists of a maximum lactide content of 85 wt. %, trimethylene carbonate in the range 5 to 20 wt. % and Ɛ-caprolactone in the range 5 to 20 wt. % (see the abstract). Hierlemann et al. fails to disclose the resorbable polymer consists of 60 to 90% w/w D,L-lactide, 5 to 35% w/w Ɛ-caprolactone and 5 to 35% w/w trimethylene carbonate.
However, it has been held that 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)
Therefore, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have selected the D,L-lactide, Ɛ-caprolactone and the trimethylene carbonate, within Applicants’ claimed ranges in order to provide specific properties such as flexibility to the wound contact material.
Regarding claims 7-9 and 21 Hierlemann et al. discloses the plaster preparation according to claim 5, wherein the resorbable polymer can initially have an inherent viscosity of 0.8 to 2.5 dl/g, particularly 1.0 to 2.0 dl/g and that following any gamma radiation treatment in the sterilized state the resorbable polymer can have an inherent viscosity of 0.7 to 1.2 dl/g, particularly 0.7 to 1.0 dl/g (see para. [0012]).
Hierlemann et al. fails to recite the resorbable polymer has an inherent viscosity between 0.5 and 2.5 dl/g, as recited in claim 7, wherein the resorbable polymer has an inherent viscosity between 0.5 and 1.6 dl/g as recited in claim 8 or wherein the resorbable polymer has an inherent viscosity between 0.9 and 1.6 dl/g, as recited in claim 9.
Again, it has been held that 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)
Therefore, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have provided the resorbable polymer with an inherent viscosity between 0.5 and 2.5 dl/g as recited in claim 7, or an inherent viscosity between 0.5 and 1.6 dl/g as recited in claim 8 or an inherent viscosity between 0.9 and 1.6 dl/g to ensure the resorbable material can be spray through a nozzle, that it atomizes into a mist, and that it adheres to the skin without being too thick or too runny.
Regarding claims 10 and 11, Hierlemann et al discloses the plaster preparation according to claim 1, wherein the terpolymer has a monomer content of up to 10% but preferably between 1 and 9 wt. %. Hierlemann et al. does not specifically disclose the terpolymer has a monomer content between 0.5 and 10% w/w as recited in claim 10 or wherein the terpolymer has a monomer content between 3 and 8% w/w as recited in claim 11.
It has been held that 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).
Therefore, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have provided the terpolymer with a monomer content between 0.5 and 10% w/w as recited in claim 10 or terpolymer with a monomer content between 3 and 8% w/w as recited in claim 11 because its decomposition behavior is determined by the proportions of monomers (see claim 14).
Regarding claim 17, Hierlemann et al. discloses the plaster preparation according to claim 1, except wherein the plaster preparation contains 5 to 30% w/w terpolymer and 70-95% w/w organic solvent. However, in Example 3, Hierlemann et al. disclose use of 240 grams of the terpolymer (see Example 1) and mixing it with 800 grams of ethyl acetate, an organic solvent. Therefore the weight % of the terpolymer and organic solvent are a result effective variable.
It has been held that "where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)
Therefore, it would have been obvious to one having ordinary skill in the art through routine experimentation to arrive at a plaster preparation containing between 5 to 30% w/w terpolymer and 70-95% w/w organic solvent in order to create a solution that can easily pass through a spray nozzle, create a very thin, uniform film upon evaporation of the solvent.
Regarding claim 18, Hierlemann et al. discloses the plaster preparation according to claim 1, except wherein the plaster preparation contains 2.8 to 7% w/w terpolymer, 31.5 to 64.4% w/w organic solvent and 30 to 65% w/w propellant.
However, in Example 3, Hierlemann et al. disclose use of 240 grams of the terpolymer (see Example 1) and mixing it with 800 grams of ethyl acetate, an organic solvent. Therefore the weight % of the terpolymer and organic solvent are a result effective variable.
It has been held that "where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)
Therefore, it would have been obvious to one having ordinary skill in the art through routine experimentation to arrive at a plaster preparation containing between 2.8 to 7% w/w terpolymer, 31.5 to 64.4% w/w organic solvent in order to create a solution that can easily pass through a spray nozzle, create a very thin, uniform film upon evaporation of the solvent. As to the propellant, they are used to create to pressure within a sprayer to assist in releasing the preparation from a sprayer. Therefore, it would have been further obvious to one having ordinary skill in the art through routine experimentation to arrive at a providing a propellant in an amount of 30 to 65% w/w propellant to assist releasing the preparation from a sprayer, as well as to assist in atomizing the preparation.
Regarding claims 22 and 23, Hierlemann et al. discloses the polymer film according to claim 21, except wherein the polymer film has an E-modulus between 1.5 and 1000 N/mm2 , as recited in claim 22 or wherein the polymer film has an E-modulus between 1.7 and 450 N/mm2, as recited in claim 23. However, Hierlemann et al. discloses the material can have a modulus less than 1,000 N/mm2 .
It has been held that 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).
Therefore, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have provided the film of Hierlemann et al. with an E modulus between 1.5 and 1000 N/mm2 as recited in claim 22 or 1.7 and 450 N/mm2 as recited in claim 23 in order to ensure the film has sufficient flexibility and is elastic to conform to the body portion upon which it is placed.
Regarding claim 24, Hierlemann et al. discloses the plaster preparation according to claim 1, wherein the terpolymer has a monomer content of up to 10% but preferably between 1 and 9 wt. %. Hierlemann et al. does not specifically disclose the polymer film has a monomer content <10% w/w.
However, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention that if the terpolymer has a monomer content of 10% w/w, then so too would the film which can simply be sprayed on a user.
Regarding claim 25, Hierlemann et al. discloses the polymer film according to claim 21, except wherein the polymer film has an extensibility between 100 to 1500%.
However, Hierlemann et al. discloses the extensibility of the material can be up to 250% (see para. 0015]).
It has been held that 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).
Therefore, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have provided the material of Hierlemann et al. with an extensibility within the claimed range to make it in order to permit optimum adaptation to portion of the body upon which it is placed (para. [0014]).
Regarding claims 27 and 28, Hierlemann et al. discloses the polymer film according to claim 21, wherein the polymer film has a strength between 0.1 and 30 N/mm2 or wherein the polymer film has a strength between 1 and 20 N/mm2. However, Hierlemann et al. discloses the material has a tensile strength of less than 30 N/mm2
Therefore, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have provided the polymer film of Hierlemann et al. with a tensile strength between 0.1 and 30 N/mm2 as recited in claim 27 or between 1 and 20 N/mm2 as recited in claim 28 in order to provide a comfortable fit when positioned on the body of a user.
Regarding claim 29, Hierlemann et al. discloses the polymer film according to claim 21, wherein except the polymer film has a thickness between 5 and 30 um. However, Hierlemann et al. disclose films having a thickness of 10 to 10 um, particularly 20 to 50 um, preferably 30-40 um (see para. [0034]).
It has been held that 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).
Therefore, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have provided the film with a thickness between 5 and 30 um specifically when the film is coating the interior surface of a medical device such as a stent so as to not impede flow.
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hierlemann et al. in view of U.S. Patent No. 4,643,179 (“Wang”).
Regarding claim 19, Hierlemann et al. discloses the plaster preparation according to claim 1, except wherein the plaster preparation additionally has at least one disinfectant, being an antibacterial active substance, selected from the group consisting of polyhexanide, phenoxyethanol, iodine, peroxides, and/or silver.
However, Wang in the disclosure of an analogous wound covering teaches it is know to provide antibacterial active substance such as silver or iodine (see claim 4) to a wound covering in order to prevent the growth of bacteria at the wound site.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KIM M LEWIS whose telephone number is (571)272-4796. The examiner can normally be reached Monday -Friday 5:30 am -11:30 am.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alireza Nia can be reached at (571)270-3076. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KIM M LEWIS/Primary Examiner, Art Unit 3786