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
Claims 1-20 are pending in this office action. All pending claims are under examination in this application.
Priority
The current application was filed on April 11, 2024 is a 371 of PCT/EP2022/078253 filed on October 11, 2022. The current application claims foreign priority to EP21202928.4 filed on October 15, 2021.
Information Disclosure Statement
Receipt of the Information Disclosure Statements filed on April 11, 2024 and June 26, 2024 are acknowledged. A signed copy of both documents are attached to this office action.
Claim Objections
Claims 1-11 and 16-20 are objected to because of the following informalities:
Claim 1: The text within the body of the claim should read, “R1, R2, and R3 are independently selected from -H, -alkyl, or -halogen; and”. A hydrogen group should not be written indicating two bonds (divalent) surrounding the motif (-H-). Also, the hyphen in front of halogen should not be longer than those used previously, to be consistent.
Dependent claims 2-11 and 16-20 are included here because they fail to cure the defects of claim 1.
Claim 2: In a similar fashion as stated with claim 1, the body of the claim should read, “R1 is selected from -H, -CH3, or -Cl.” All of these groups can only be bonded to one additional atom, and -H-, -CH3-, or -Cl- is inappropriate.
Claim 4: Please use only one hyphen with the N,N-dichloro unit.
Claim 11: Please amend the body of the claim. The text currently reads, “…a superabsorbent or superabsorbent fibers not functionalized with a N-chloro or N,N-dichloro sulfonamide…”, which is not clear to the skilled artisan.
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.
Claim 5 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.
Claim 5 states, “…as determined by the method provided in the description…”. This reference to the specification within the claim is not allowed. Please amend in as much detail as necessary for the method. As it is currently stated, the claim is unclear and indefinite.
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 non-obviousness.
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 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Parkhurst et al. (US2005/0008606A1) in view of Schneider et al. (US2013/031328A1), Schneider et al. (US8,425,890B2), Schneider et al. (US8,003,823B2), and Wang et al. (Science of the Total Environment, 2018).
[The Examiner is going to introduce each reference and then combine them where appropriate to reject the instant claims.]
1. Parkhurst et al.
Parkhurst et al. is the closest prior art to the present invention as it teaches odor-mitigating compositions (see title). Additionally, Parkhurst et al. disclose that the invention includes compositions, devices, systems and methods for mitigating odors, pollutants and toxins from a gaseous or liquid environment. The present invention relates to devices that contain a formulation for removing foul odors from the air. In certain embodiments the present invention provides odor-mitigating reagents that are substantially incapable of leaching from the device during ordinary use. The present invention also contemplates applications where the invention can be safely worn in contact with the user's skin or hair. Certain embodiments of the invention therefore particularly relate to devices such as diapers, shoe liners, sanitary pads, wound dressings, face masks and the like. Another aspect of the invention contemplates applications wherein the device can be used within indoor and outdoor settings where it is desirable that the odor-controlling reagents not leach out of the device as a result of contact with liquids. Related embodiments of the invention include landfill odor abatement covers and various interior and industrial air fresheners (see abstract).
2. Schneider et al.
Schneider et al. teach waste container with odor control (see title). In addition, Schneider et al. disclose waste containers which include a vessel body with an opening for receiving waste materials, a removable cover/lid for operably enclosing said opening, and an odor control dispenser are disclosed. The odor control dispenser selectively dispenses an odor control agent into the vessel body when activated (see abstract).
3. Schneider et al. ‘890
Schneider et al. ‘890 teach odor-controlling bodily fluid absorber (see title). Furthermore, Schneider et al. ‘890 disclose an odor-controlling bodily fluid absorbent member comprises (a) an absorbent material or substrate; and (b) a halo active aromatic sulfonamide compound of Formula (I):
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wherein R1, R2, R3, R4, R5, X, M, and n are as described herein; and wherein at least one of R1, R2, R3, R4, and R5 is not hydrogen. The absorbent member effectively controls odor arising from various body fluids (see abstract).
4. Schneider et al. ‘823
Schneider et al. ‘823 teach halo active aromatic sulfonamide organic compounds and odor control uses therefor (see title). Also, Schneider et al. ‘823 disclose aromatic N-halosulfonamide organic compounds have been known for over one hundred years. The ability of these compounds to release active halogen ions has been utilized in a
range of biocidal and fungicidal applications. The most widely used halogen sulfonamide organic compound for these applications is Chloramine-T. This invention deals with the new use of discovered compositions of matter, halo active aromatic sulfonamide organic compounds and use of solutions of these compounds as, odor control agents. The odor control solutions may be buffered to a predetermined pH. The
odor control compositions may further incorporate small percentages of low molecular weight alcohols and wetting agents (see abstract).
5. Wang et al.
Wang et al. teach factors affecting the water odor caused by chloramines during drinking water disinfection (see title). Furthermore, Wang et al. disclose chloramine disinfection is one of the most common disinfection methods in drinking water treatment. In this study, the temporal variability of water odors during monochloramine auto-decomposition was investigated to elucidate the characteristics of odor problems caused by adopting chloramine disinfection in tap water. Odor intensities and dominant odorant contributions were determined using the flavor profile analysis (FPA) and odor active value (OAV), respectively. During auto-decomposition of monochloramine, Cl2/N molar ratio, pH, temperature, and the presence of NOM all affected odor intensity and odor temporal variation in drinking water. In general, decreasing pH from 8.5 to 6.0 led to increasing perceived odor intensity due to the formation of dichloramine. The major odorants responsible for chlorinous odor under acidic and non-acidic conditions were dichloramine and monochloramine, respectively. Chloraminated water with a Cl2/N molar ratio of 0.6 or NOM concentration <2 mg-C L-1 inhibited odor intensity. Furthermore, the influence of rechlorination on chlorinous odor intensity for chloraminated water should not be neglected. The results of this study will be beneficial for the control of chlorinous odors caused by chloramine disinfection in drinking water
(see abstract).
Combination of Parkhurst et al., Schneider et al., and Schneider et al. ‘890
Regarding instant claims 1 and 18, Parkhurst et al., Schneider et al., and Schneider et al. ‘890 teach a functionalized polymer particles of fibers for odor control in wound care. The necessary citations within Parkhurst et al., Schneider et al., and Schneider et al. ‘890 that pertain to instant claims 1 and 18 are presented in Table I.
Table I
Instant Claims 1 and 18
Parkhurst et al., Schneider et al., and Schneider et al. ‘890 Citations
A polymer particle or a polymer fiber covalently bonded to a N-chloroamine or a N,N-dichloroamine or covalently bonded to a N-chlorosulfonamide or N,N- dichlorosulfonamide, for removing a volatile organic compound, wherein a moiety as bonded to the polymer particle or the polymer fiber is of a structure selected from the following:
Parkhurst et al. disclose compositions, devices, systems and methods for mitigating odors, pollutants and toxins from a gaseous or liquid environment. The present invention relates to devices that contain a formulation for removing foul odors from the air. In certain embodiments the present invention provides odor-mitigating reagents that are substantially incapable of leaching from the device during ordinary use. The present invention also contemplates applications where the invention can be safely worn in contact with the user's skin or hair. Certain embodiments of the invention therefore particularly relate to devices such as diapers, shoe liners, sanitary pads, wound dressings, face masks and the like. Another aspect of the invention contemplates applications wherein the device can be used in indoor and outdoor settings where it is desirable that the odor-controlling reagents not leach out of the device as a result of contact with liquids. Related embodiments of the invention include landfill odor abatement covers and various interior and industrial air fresheners (see abstract within Parkhurst et al.).
Parkhurst et al. disclose within Example 8 a polymeric version for restroom application. The important chemical components are not lost because of polymeric incorporation of these compounds. Mass transfer effects that normally occur during operation of the device would use up these components. (see Example 8 within Parkhurst et al.).
Schneider et al. disclose polymeric formula VI:
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(see paragraph [0130] within Schneider et al.). Where Q is a divalent linkage and y is 0 or 1 (see paragraph [0131] within Schneider et al.). Paragraphs [0132-0134] within Schneider et al. disclose the necessary claim limitations (substituents) that meet the requirements of instant claim 1.
Scheider et al. does not disclose support for the linker and CH2 moiety:
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beyond the following examples; methyl formate [Polymer-CH2-C(O)O-Ph; (see paragraph [0138] and [0148] within Schneider et al.)], ester [Polymer-O(O)C-Ph; see paragraph [0136] within Schneider et al.)], or a generic divalent linkage bridging the polymer and sulfonamide. However, this could easily be expanded to include the appropriate groups by a skilled artisan (POSITA; person of ordinary skill in the art) based on the commercial availability of the polymer and various sulfonamides.
Schneider et al. ‘890 disclose support for the use of sulfonamide analogues for the use in odor-controlling bodily fluids (see title, abstract, and claims within Schneider et al.).
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It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify Parkhurst et al. with the teachings of both Schneider et al. and Schneider et al. ‘890 to create a functionalized polymer particles of fibers for odor control in wound care. The motivation for doing so would have been to incorporate the odor controlling bodily fluid absorber, sulfonamide, into the polymer backbone while not leaching out of the wound dressing.
Regarding instant claim 2, Parkhurst et al., Schneider et al., and Schneider et al. ‘890 teach wherein L-(CH2)y is -NH-(CH2)y; and/or y is from 1 to 20; and/or R1 is selected from -H, -CH3, or -Cl; and/or halogen is F, Cl or Br and/or R2 and R3 are -H-.
Schneider et al. disclose wherein R1 is selected from -H, -CH-3, and halogen (-F, -Cl, or -Br and R2 and R3 are -H (see paragraph [0132] within Schneider et al.). Also, please refer to the structure, discussion, and citations within instant claim 1 for the necessary rejection text.
Regarding instant claim 3, Parkhurst et al., Schneider et al., and Schneider et al. ‘890 teach wherein the polymer is based on polyacrylic acid, partially hydrolyzed acetyl- poly(vinylalcohol) or poly(vinyl alcohol), optionally a cross-linked polymer network of polyacrylic acid, partially hydrolyzed acetyl-poly(vinylalcohol) or poly(vinyl alcohol), or any copolymer or mixture thereof.
Schneider et al. disclose the polymer may have any polymeric form. For example, the polymer may be a linear polymer, a nonlinear (branched) polymer, a crosslinked polymer, a copolymer, a graft copolymer, or a block copolymer. Similarly, the polymer may comprise only one monomer or several monomers. However, at least one monomer must allow attachment of or subsequent development of the aromatic N-sulfonamide moiety.
Additionally, the backbone of the polymer comprises a monomer which allows attachment of or subsequent development of the aromatic N-sulfonamide moiety as a pendant group. The simplest backbone is a polyaliphatic backbone such as poly(ethylene), poly(vinyl alcohol), or poly(allyl alcohol). The backbone may also comprise other monomers which do not contain the aromatic N-sulfonamide moiety (see paragraph [0149-0150] within Schneider et al.).
Regarding instant claim 4, Parkhurst et al., Schneider et al., and Schneider et al. ‘890 teach wherein at least 0.1% of the alcohol or carboxylic acid groups originally present in the polymer are functionalized with a N-chloro or N,N-dichloro unit.
Schneider et al. disclose functionalization of the resulting sulfonamide with a N-chloro unit (see paragraph [0133] within Schneider et al.). Furthermore, please refer to the structure, discussion, and citations within instant claim 1 for the necessary rejection text.
Regarding instant claim 5, Parkhurst et al., Schneider et al., and Schneider et al. ‘890 teach wherein the amount of active chlorine as determined by the method provided in the description is from 0.1% to 20% (w/w).
A skilled artisan (POSITA) could modify the synthesis of the N-chlorosulfonamide polymer disclosed within Schneider et al. to be within the 0.1% to 20% (w/w) range.
Regarding instant claim 6, Parkhurst et al., Schneider et al., and Schneider et al. ‘890 teach wherein the median D50 particle diameter of the polymer particle is from 80 mm to 600 mm; or wherein the average diameter of the fiber is from 1 mm to 300 mm.
Schneider et al. does not disclose the D50 particle diameter or average diameter of the fiber. However, the prior art of record is close to the disclosure of the instant application and would therefore the polymer would have a similar D50 and/or average diameter of the fiber as the instant claim 6 limitation.
Regarding instant claim 7, Parkhurst et al., Schneider et al., and Schneider et al. ‘890 teach a wound dressing, comprising the polymer particle or polymer fiber of instant claim 1.
Parkhurst et al. disclose a wound dressing comprising the odor-mitigating composition of instant claim 1 (see abstract within Parkhurst et al.). In addition, please refer to the structure, discussion, and citations within instant claim 1 for the necessary rejection text.
Regarding instant claim 8, Parkhurst et al., Schneider et al., and Schneider et al. ‘890 teach the wound dressing according to instant claim 7, comprising at least 5% by weight of said polymer particle or polymer fiber, relative to the overall weight of the dressing, and/or wherein the polymer particle or polymer fiber have a grammage of at least 15 g/m2, of the overall wound dressing.
A skilled artisan (POSITA) could modify the synthesis of the N-chlorosulfonamide polymer disclosed within Schneider et al. comprising either at least 5% by weight of said polymer particle or polymer fiber, relative to the overall weight of the dressing, and/or wherein the polymer particle or polymer fiber have a grammage of at least 15 g/m2, of the overall wound dressing.
Regarding instant claims 9-11, Parkhurst et al., Schneider et al., and Schneider et al. ‘890 teach the wound dressing according to instant claim 7, furthermore comprising at least one of the following: (a) a backing layer; (b) at least one absorbent layer; and (c) a wound contact layer, said wound contact layer optionally comprising a silicone gel.
Parkhurst et al. disclose a wound dressing comprising the odor-mitigating composition of instant claim 1 (see abstract within Parkhurst et al.). Furthermore, as part of the wound dressing design Parkhurst et al. disclose layers (see paragraphs [0015], [0104], [0116], [0120] and claim 28; all within Parkhurst et al.) such as a backing layer. Moreover, Parkhurst et al. disclose an absorbent layer (see paragraphs [0038], [0075], [0106] and claim 40; all within Parkhurst et al.).
Regarding instant claims 12 and 16, Parkhurst et al., Schneider et al., and Schneider et al. ‘890 teach a method of controlling odor above a wound space, said method comprising at least the following steps: (a) providing a polymer particle or a polymer fiber according to instant claim 1 in a wound dressing; (b) bringing at least a fraction of said polymer particle or polymer fiber into contact with at least one volatile organic compound that is exuded from a wound and/or from the human skin in the vicinity of a wound; and (c) chemically reacting said volatile organic compound with the N-chloro or N,N-dichloro group as covalently bonded to said polymer particle or polymer fiber thus at least partially reducing odor emanating from a wound or from the area around a wound.
Please see the discussion and citations within instant claims 9-11 for the necessary rejection text. Additionally, Schneider et al. ‘890 disclose the use of N-chlorosulfonamide monomers to control the odor of bodily fluids (see title, abstract, and claims within Schneider et al. ’890). Chemically reacting said volatile organic compound with the N-chlorosulfonamides covalently bonded to said polymer particle or polymer fiber of instant claim 1 would produce the same positive result of at least partially reducing odor emanating from a wound or from the area around a wound.
Regarding instant claims 13 and 14, Parkhurst et al., Schneider et al., and Schneider et al. ‘890 teach wherein said at least one volatile organic compound is selected from the group consisting of a heteroarylic, arylic compounds, sulfides, di-sulfides, trisulfides, ketones, alcohols, aldehydes, amines, carboxylic acids, and esters.
Schneider et al. ‘890 disclose how the N-chlorosulfonamide monomers react with odor causing compounds, such as volatile organic compounds (VOCs) (see column 5, lines 4-36 within Schneider et al.; see also PTO-892 NPL W; cadaverine). Parkhurst et al. disclose volatile organic compounds such as carboxylic acids, sulfur compounds, and amines (see paragraph [0161] within Parkhurst et al.).
Regarding instant claim 15, Parkhurst et al., Schneider et al., and Schneider et al. ‘890 teach wherein the wound is selected from a chronic wound and/or an infected wound.
A skilled artisan (POSITA) could identify a patient cohort having both chronic and infected wounds for use of wound dressing administration.
Combination of Parkhurst et al., Schneider et al., Schneider et al. ‘890, and Schneider et al. ‘800
Regarding instant claim 17, Parkhurst et al., Schneider et al., Schneider et al. ‘890, and Schneider et al. ‘800 teach the polymer particle or polymer fiber of instant claim 1, wherein the structure is
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Both Schneider et al. ‘800 and Schneider et al. ‘890 disclose the monomer N-chloroarylsulfonamides (see abstract, title, and claims within both references). Since Schneider et al. ‘890 states that it is the N-chlorosulfonamide portion of the functional group that reacts with the odor forming VOCs (see instant claims 13 and 14) a skilled artisan (POSITA) would substitute in an alkyl chain rather than an aryl group under routine experimental conditions (see PTO-892 NPL X). The alkyl or aryl group is neutral to the bioactivity of the N-chlorosulfonamide. Incorporation of this monomer into the polymeric backbone would be carried out under standard conditions.
Regarding instant claim 19, Parkhurst et al., Schneider et al., Schneider et al. ‘890, and Schneider et al. ‘800 teach the polymer particle or polymer fiber of instant claim 1, wherein the structure is
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Both Schneider et al. ‘800 and Schneider et al. ‘890 disclose the monomer N-chloroarylsulfonamides (see abstract, title, and claims within both references). Since Schneider et al. ‘890 states that it is the N-chlorosulfonamide portion of the functional group that reacts with the odor forming VOCs (see instant claims 13 and 14), a skilled artisan (POSITA) would substitute in a heterocycle (thiophene) rather than an aryl group under routine experimental conditions (see PTO-892 NPL V). The thiophene or aryl group is neutral to the bioactivity of the N-chlorosulfonamide. Incorporation of this monomer into the polymeric backbone would be carried out under standard conditions.
Combination of Parkhurst et al., Schneider et al., Schneider et al. ‘890, and Wang et al.
Regarding instant claim 20, Parkhurst et al., Schneider et al., Schneider et al. ‘890, and Wang et al. teach the polymer particle or polymer fiber of instant claim 1, wherein the structure is
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Schneider et al. ‘890 states that it is the N-chloro-portion of the functional group that reacts with the odor forming VOCs (see instant claims 13 and 14). Furthermore, Wang et al. disclose how drinking water is disinfected with chloramines (see title and abstract within Wang et al.). Therefore, a skilled artisan (POSITA) would substitute in an alkyl N-chloro moiety rather than an aryl group under routine experimental conditions to obtain the desired bioactivity. Incorporation of this monomer into the polymeric backbone would be carried out under standard conditions.
Analogous Art
The Parkhurst et al., Schneider et al., Schneider et al. ‘890, Schneider et al. ‘823, and Wang et al. references are directed to the same field of endeavor as the instant claims, that is, functionalized polymer particles of fibers for odor control in wound care, as disclosed within instant claim 1.
Obviousness Analysis
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the odor-mitigating compositions disclosed by Parkhurst et al., using the teachings of Schneider et al., Schneider et al. ‘890, Schneider et al. ‘823, and Wang et al. in order to arrive at the subject matter of the instant claims.
The Parkhurst et al., Schneider et al., Schneider et al. ‘890, Schneider et al. ‘823, and Wang et al. references all have considerable overlap in the odor control arts. In this instance, Parkhurst et al. supplies the wound dressing application criteria, Schneider et al. supplies the N-chlorosulfonamide in polymeric form, Schneider et al. ‘890 and Schneider et al. ‘823 further support the use of N-chlorosulfonamides in monomeric forms, while Wang et al. supplies an example using chloramines in drinking water disinfection to support the use of alkyl chloramines. All references are directed to odor control and therefore constitute analogous art under MPEP §2141.01(a). A POSITA would have reasonably consulted the five references when seeking to develop functionalized polymer particles of fibers for odor control in wound care.
Given these teachings, a POSITA would have been motivated to combine the wound dressing as disclosed by Parkhurst et al., the N-chlorosulfonamide in polymeric form supplied by Schneider et al., the support the use of N-chlorosulfonamides in monomeric forms disclosed by Schneider et al. ‘890 and Schneider et al. ‘823, and the alkyl chloramines from the example using chloramines in drinking water disinfection disclosed by Wang et al.
The modification constitutes a simple substitution of one known element for another to obtain a predictable result [MPEP §2143(I)(B)].
The combination represents the use of a known technique to improve a similar composition in the same way [MPEP §2143(I)(C)].
The art provides a finite number of identified, predictable solutions, and the POSITA would have pursued the claimed configuration with a reasonable expectation of success [MPEP §2143(I)(E); KSR].
The combination of the wound dressing taught by Parkhurst et al. along with the use of the necessary claim limitations taught by Schneider et al., Schneider et al. ‘890, Schneider et al. ‘823, and Wang et al. would allow a research and development scientist (POSITA) to develop the invention taught in the instant application.
Furthermore, the additional claim limitations taught by Schneider et al., Schneider et al. ‘890, Schneider et al. ‘823, and Wang et al. would have been viewed by a POSITA as routine design optimizations or known modifications within odor control of wound dressings. The motivation for doing so would have been to incorporate the odor controlling bodily fluid absorber, sulfonamide, into the polymer backbone while not leaching out of the wound dressing. Implementing these features in Parkhurst et al.’s wound dressing compositions would not require more than ordinary skill or routine experimentation.
Accordingly, the combination of Parkhurst et al., Schneider et al., Schneider et al. ‘890, Schneider et al. ‘823, and Wang et al. provides all the elements of the claimed invention. The resulting wound dressing comprising polymeric N-chlorosulfonamides, constitute no more than the predictable outcome of combining familiar prior art components, and therefore the claimed subject matter would have been obvious to a POSITA prior to the effective filing date of the invention.
Conclusion
No claims are allowed.
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/JOHN W LIPPERT III/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
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