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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/14/25 has been entered.
Claim Status
Claims 1-16 are cancelled.
Claims 17-29 are pending.
Withdrawn rejections
Applicant's amendments and arguments filed 11/14/25 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Any rejection and/or objection not specifically addressed below is herein withdrawn. Claims 17-29 were rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. Claim(s) 27 and 28 were rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mwiiri et al. (Molecules 2020 (Published 10/19/2020), 25, 4799; doi:10.3390/molecules25204799; 21 pages). Applicant has amended the claims to overcome the rejections. The product of Mwiiri et al. is fibrous and not “non-fibrous” as claimed.
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 17-29 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 17 has been amended to recite “a continuous film-forming layer” and “a homogeneous, non-fibrous wound-dressing layer having a substantially uniform thickness”. MPEP 2163.06 states: “Applicant should therefore specifically point out the support for any amendments made to the disclosure.” Applicant has not directed the Examiner to the support in the specification for the amendments. A text search of the specification does not hit on “a continuous film-forming layer” or “a homogeneous, non-fibrous wound-dressing layer having a substantially uniform thickness”. For example, while the term “fiber” appears in [3] as it relates to the prior art, there does not appear to be any disclosure of “non-fibrous”. Moreover, the absence of a claimed element does not provide a basis for its exclusion. In this regard, see MPEP 2173.05(i): The mere absence of a positive recitation of a claim element in the Specification is not basis for its express exclusion in the claims. The mere absence of a positive recitation is not basis for an exclusion. Any claim containing a negative limitation which does not have basis in the original disclosure should be rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, as failing to comply with the written description requirement. Additionally, there are no structural figures to derive the claimed limitations in question either. Nor could the Examiner readily ascertain the scope of the claimed limitations from the disclosure as filed. Consequently, those limitations were not described in the specification as filed, and person skilled in the art would not recognize in the applicant’s disclosure a description of the invention as presently claimed. Therefore, it is the Examiner’s position that the disclosure does not reasonably convey that the inventor had possession of the subject matter of the amendment at the time of filing of the instant application.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 17-21, 23 and 26-29 are rejected under 35 U.S.C. 103 as being unpatentable over Texier-Nogues et al. (WO2016198238) and Daniels et al. (WO2019243988).
Applicant claims a multi-step process for the preparation of wound dressing from a phospholipid-containing nanodispersion.
Please note from the MPEP: “Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure.” See M.P.E.P § 2111.04; see also M.P.E.P §§ 2103(C) and 2173.05(h).
Level of Ordinary Skill in the Art
(MPEP 2141.03)
MPEP 2141.03 (I) states: “The “hypothetical ‘person having ordinary skill in the art’ to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art.” Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988). The level of skill is that of a wound dressing research scientist, as is the case here, then one can assume comfortably that such an educated artisan will draw conventional ideas from wound dressing engineering, wound dressing techniques and components— without being told to do so.
In addition, the prior art itself reflects an appropriate level (MPEP 2141.03(II)).
Determination of the scope and content of the prior art
(MPEP 2141.01)
Regarding claims 17 and 23, Texier-Nogues et al. teach methods of making a hydrogel with a polymer capable of forming a hydrogel (Claims 13-15) with nanoparticles homogenously distributed within the material (Claim 12) for use in wound dressing (Claims 16 and 19). Texier-Nogues et al. teach two alternative processes for preparing the hydrogel where in method A, “a nanoemulsion comprising a continuous aqueous phase and nanoparticles (which is the dispersed phase of the nanoemulsion) is first provided and then mixed with a polymer capable of forming a hydrogel. The nanoparticles form the dispersed phase of the nanoemulsion.” (Page 16, lines 25 through page 17, line 24). To provide the nanoemulsion, which reads on steps a)- b) of instant claim 17, Texier-Nogues et al. teach:
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Mixing of the dispersion with a polymer reads on instant step c) of claim 17. Texier-Nogues et al. teach that the material can be supported on a substrate (Page 14, line 26), that can be glass or polyurethane foam, where the hydrogel applied to a surface of the substrate and is supported on the substrate after the drying step, which can be carried out by freeze-drying or by evaporating water in an oven at elevated temperature (Page 22, lines 30-36 and Page 23, lines 1-12). It is the Examiner’s position that application to a surface of a substrate reads on coating the dispersion onto a support/carrier step d) of instant claim 17 and is subsequently dried reading on step e) of claim 17. Optional step f) is not required. “Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure.” See M.P.E.P § 2111.04; see also M.P.E.P §§ 2103(C) and 2173.05(h). Further regarding step b), Texier-Nogues et al. teach that: “The emulsion is then processed with the homogeneizer using the number of cycles necessary to achieve the targeted size for the nanoparticles.” (Page 21, lines 17-18) and “the diameter of the obtained nanoparticles is generally greater than 10 nm and smaller than 500 nm, preferably between 20 and 400 nm, most preferably between 30 and 300 nm” (Page 21, lines 22-24), thus having at least 90% of the particle droplets with a diameter of less than 10 µm. In Figure 1 of Texier-Nogues et al., the scope of the disclosure of Texier-Nogues et al. appears to show a continuous film-forming layer that is homogeneous, non-fibrous wound-dressing layer having a substantially uniform thickness (Page 30, line 8 and Figure 1). And Texier-Nogues et al. teach preparation of chitosan films comprising F50 nanoemulsions (Page 32, 1.2. Preparation of chitosan films including F50 nanoemulsions) and in “film form” (Page 15, line 15).
Texier-Nogues et al. teach that: “the expression « dispersed phase » designates the nanoparticles comprising the solubilising lipid / the amphiphilic lipid / the co-surfactant I the optional oil / the optional imaging agent/ the optional therapeutic agent the optional cationic surfactant/ the optional helper lipid. The dispersed phase is generally free of aqueous phase. The term « nanoparticle » encompasses both the nanoparticles (also called droplets) of liquid oil and the solid nanoparticles derived from emulsions of oil-in-water type in which the dispersed phase is solid. In the present application, the term "nanoparticle" is used both for the nanoparticles of the dispersed phase of the nanoemulsion/ material in hydrogel form and for the nanoparticles after the drying step (i.e. in the absence of aqueous phase).” (Page 28, lines 14-24).
Regarding claims 17 and 29, Texier-Nogues et al. teach using a sonicator, microfluidizer or high-pressure homogenizer (Page 21, lines 8-9, 19-20), thus reading on step b) of claim 17.
Regarding claims 17 and 27, Texier-Nogues et al. teach using phospholipids, particular mention is made of phosphatidylcholine, phosphatidyl ethanolamine, phosphatidyl inositol, phosphatidyl serine, sphingomyeline, DOPE and mixtures thereof (Page 28, lines 30-35) and lecithin (Page 29, lines 1-5), thus reading on step a) of instant claim 17. Accordingly, the process of Texier-Nogues et al. forms a wound dressing on the basis of phospholipid containing nanodispersions.
Regarding claim 17, Texier-Nogues et al. teach that: “The oils are generally selected from among biocompatible oils, and in particular from 10 among oils of natural origin (vegetable or animal) or synthetic. Among these oils particular mention can be made of oils of natural vegetable origin amongst which are included soybean, flax, palm, groundnut, olive, grape seed and sunflower seed oil; synthetic oils which particularly include triglycerides, diglycerides and monoglycerides. These oils may be first press, refined or inter-esterified oils. The preferred oils are soybean oil and flax oil.” (Page 8, lines 9-15).
Regarding claims 17 and 27-29, Daniels et al. is directed to wound dressing and teach in claims 9-10 and 13:
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Daniels et al. teach using 2.5% Phospholipon 90H, 1% sunflower oil, 0.5% birch bark extract and the remainder water with 10% PVA in a 60%/40% blend (Page 13, Table 1). Thus, the process of Daniels et al. forms a wound dressing with the same amounts of components on the basis of phospholipid containing nanodispersions.
Regarding claim 17, Daniels et al. teach in claim 4:
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Regarding claim 17, Daniels et al. teach: “The oil can be any suitable pharmaceutically acceptable oil like castor oil, corn oil, coconut oil, linseed oil, olive oil or peanut oil whereby sunflower oil is preferred.” (Page 4, lines 14-15) and the polymer can be polyvinyl alcohol (Claim 11).
Regarding claim 18, Daniels et al. teach 0.1 to less than 5.0% by weight birch bark extract (Claim 8).
Regarding claim 19, Daniels et al. teach in claim 7:
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Regarding claim 20, Daniels et al. teach in claim 5:
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Regarding claim 23, Daniels et al. teach that under reduced pressure the liquid evaporates and the fiber is dried (Page 9, lines 18-19).
Regarding claims 27-28, Daniels et al. teach use in the treatment of wound (Claim 14) and is a wound dressing (Page 6, lines 1-2).
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02) and Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
1. The difference between the instant application and Texier-Nogues et al. is that Texier-Nogues et al. do not expressly teach adding: 1-15% phospholipid; 1-10% pharmaceutically acceptable oil; 0.05 to 5% by weight birch extract with the components of instant claim 19 and the remainder water and mix with an aqueous polyvinyl alcohol solution containing 5-20% by weight of the polymer in a weight ratio of aqueous polyvinyl alcohol solution to nanodispersion of 25:75 to 75:25. This deficiency in Texier-Nogues et al. is cured by the teachings of Daniels et al.
1. It would have been obvious to one of ordinary skill in the art before to the effective filing date of the claimed invention to perform the method of Texier-Nogues et al. and add 1-15% phospholipid; 1-10% pharmaceutically acceptable oil; 0.05 to 5% by weight birch extract with the components of instant claim 19 and the remainder water and mix with an aqueous polyvinyl alcohol solution containing 5-20% by weight of the polymer in a weight ratio of aqueous polyvinyl alcohol solution to nanodispersion of 25:75 to 75:25, as suggested by Daniels et al., and produce the instant invention.
One of ordinary skill in the art would have been motivated to do this because for the following sound articulated reasoning with rational underpinning based upon the evidence. The material of Texier-Nogues et al. can comprise therapeutic agents (Page 8, line 16 through page 9, line 23) including anti-inflammatories (Page 8, line 34), antimicrobial agents (Claim 6), chemical compounds capable of promoting wound healing (Claim 7) and several therapeutic agents (Page 9, line 34). Thus, the process of Texier-Nogues et al. is open to the inclusion of other known therapeutic agents for wound healing. Daniels et al. teach that: “Birch bark extract has antibacterial activity and also activity against plasmodia or viruses. Moreover, it is anti-inflammatory and helpful in the healing of wounds.” (Page 1, lines 13-15) and clinically proven to speed up wound healing (Page 2, lines 1-2). Furthermore Daniels et al. state: “Birch bark extracts have a high content of triterpenes which are biologically active secondary plant metabolites. Their various pharmacological properties like anti-inflammatory, anti-viral, anti-cancer activity and wound healing effects are well investigated and specified in the literature.” (Page 3, lines 22-25) and: “The birch bark extract contains chemical constituents which are useful in pharmaceutical applications since antiviral, antibacterial and anti-inflammatory activity has been reported. Therefore, birch bark extracts can be used as antibacterial or antifungal agents and in wound healing.” (Page 3, lines 23-26). Accordingly, the ordinary artisan would add 1-15% phospholipid; 1-10% pharmaceutically acceptable oil; 0.05 to 5% by weight birch extract with the components of instant claim 19 and the remainder water in the amounts taught by Daniels et al., for the beneficial wound healing properties of the birch extract, to the process of Texier-Nogues et al. to a make a wound dressing with those desirable properties of birch extract with a reasonable expectation of success. With regard to the limitation claim 17, step c), Texier-Nogues et al. is open to polymers that are capable of forming hydrogels and Daniels et al. provide guidance to the ordinary artisan to employ 10% PVA in a 60%/40% blend (Page 13, Table 1). Thus, with the combined references in hand it is merely judicious selection of known polymers such as polyvinyl alcohol and routine optimization of the amounts including an aqueous polyvinyl alcohol solution containing 5-20% by weight of the polymer in a weight ratio of aqueous polyvinyl alcohol solution to nanodispersion of 25:75 to 75:25 by the ordinary artisan with a reasonable expectation of success.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Texier-Nogues et al. (WO2016198238) and Daniels et al. (WO2019243988), as applied to claims 17-21, 23 and 26-29 above, in further view of Fitzgerald et al. (GB2093703) and Daniels et al. (WO2018017576; hereinafter DanielsWO2018).
Applicant claims:
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The references of Texier-Nogues et al. and Daniels et al. are discussed in detail above.
The combination of Texier-Nogues et al. and Daniels et al. do not expressly teach applying the nanodispersion dispersed in the polymer is applied to a carrier with foaming. However about 40 years ago, Fitzgerald et al. taught that in the manufacture of wound dressings the ingredients are fed into a mixing and dispensing machine and suitable foam layers can be made by casting the foaming mixture before it sets onto a suitable surface (Page 3, 115-120), which is later cut up into suitable sized dressing (Page 3, 75-78). Further, Fitzgerald et al. taught that an embossed patterned casting sheet with a solution cast onto the sheet and then dried and after drying separating the embossed pattern sheet (Page 4, 0-19). Accordingly, Fitzgerald et al. present a well-known technique to produce wound dressing by foaming onto a surface of a carrier, which can then be later separated. Moreover, it is known through the teachings of DanielsWO2018 that water-in-oil foams containing birch bark extract to improve wound healing are known to the ordinary artisan (Title; Abstract) and contain sunflower oil and phosphatidylcholine as an emulsifier (Claims 14 and 23; Example 1 [074]; Table 1), which is produced by foaming an emulsion containing the components (Claims 24 and 32, [074]). Consequently, in view of the combination of references, it is obvious to create a foam from an emulsion of the instantly claimed components and apply it to a support/carrier. It is simply a known alternative means of employing the emulsion composition for wound healing purposes. The ordinary artisan would do so in light of the combined teachings with a reasonable expectation of success. The Examiner noted that Texier-Nogues et al. taught glass or polymeric substrates. It is the Examiner’s position that aluminum foil, plastic foil, cotton fabric or fleeces and polymeric fabrics or fleeces are conventional substrates known to the artisan in this art absent any criticality of the carrier/support material.
Claims 24 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Texier-Nogues et al. (WO2016198238) and Daniels et al. (WO2019243988), as applied to claims 17-21, 23 and 26-29 above, in further view of Webster, DF (US4664662).
Applicant claims:
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The references of Texier-Nogues et al. and Daniels et al. are discussed in detail above.
Regarding claims 24-25, Texier-Nogues et al. teach cutting the materials into small blocks with a razor blade after drying (Page 56, lines 26-27). The combination of Texier-Nogues et al. and Daniels et al. do not expressly teach the dried layer has a thickness of 0.1 to 5 mm and pieces of 1-100 cm2. However, Webster is directed to wound dressing (Title; Abstract) and teaches cured, hence dried, sheets having a thickness of from 1-15 mm (Column 3, lines 65-67) and preferably 3-5 mm (Column 4, line 1). Webster teaches: “One preferred form is a dressing of rectangular shape. The size of such dressings will depend upon the type of wound to which they are applied. Small pressure sores may require a dressing of width 1 to 5 cm and length 1 to 10 cm. Larger leg ulcers and burns may require dressings which are 10 cm to 20 cm X 30 cm in a rectangular shape” (Column 8, lines 30-37) and can be done by mechanical means (Column 4, lines 6-14). Thus, a wound dressing of 1 cm X 1cm would provide a 1 cm2 area and a 10 cm by 20 cm would provide a 200 cm2 area, thus embracing the claimed range. See MPEP 2144.05(I): 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). Furthermore, the ordinary artisan would optimize the size to fit the wound. Accordingly, the ordinary artisan would have a reasonable expectation of success of preforming the method of the combined references and producing a wound dressing with a thickness of 0.1 to 5 mm and mechanically comminuting it into pieces of 1-100 cm2 in the absence of evidence to the contrary.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
From the combined teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date, as evidenced by the combined references, especially in the absence of evidence to the contrary.
Response to Arguments:
Applicant’s arguments filed on 11/14/25 have been carefully considered but are not persuasive. Applicant argues the 103 rejections together.
On page 6 of remarks, Applicant asserts: “Texier-Nogues seeks a
3D sponge-like matrix, whereas Applicant's invention provides a 2D film-type dressing.” Respectfully, the Examiner does not agree. The specification teaches that the film can be porous [41] similar to a sponge [043]. Also, Texier-Nogues et al. is directed to wound healing dressing (Claim 16), which is the same endeavor as Applicant. Applicant’s argument is not persuasive.
On page 7 of remarks, Applicant asserts that Texier-Nogues et al. fails to disclose several critical features required by claim 17; namely steps (a), (b), (c), (d) and (e). Applicant argues that the nanoparticles of Texier-Nogues et al. are pre-formed or commercially obtained but there is no oil phase or quantitative ratios. That is simply incorrect as Texier-Nogues et al. teach: “Forming the nanoparticles under shear effect in step A 1 c) (method A) is preferably performed using a sonicator or a high pressure homogenizer.” (Page 21, lines 10-11; see also lines 15-18 teaching mixing of the aqueous and oily phase under high pressure homogenization). Applicant further argues that the method of Texier-Nogues et al. produces a porous scaffold which is opposite in morphology. Applicant asserts: “Texier-Nogues also does not teach feature (d) coating mixture as continuous film on carrier or (e) drying to form homogeneous, non-porous layer.” However, the Examiner has carefully mapped how Texier-Nogues et al. reads on each claimed step in the rejection above. Applicant has not pointed to any error or mischaracterization by the Examiner in the interpretation of the disclosure of Texier-Nogues et al. Furthermore, the test for obviousness is "what the combined teachings of the references would have suggested to those of ordinary skill in the art." In re Keller, 642 F.2d 4I3, 425 (CCPA I98I) (MPEP 2145(III)). In this case, the rejection is over a combination of references and the ordinary artisan would have a reasonable expectation of success in combining the references to produce the claimed method. Additionally, the instant claims do not have any limitations directed to a non-porous layer. Just because a layer is homogenous, does not convey that it is also non-porous. Applicant further argues that: “None of these references discloses or suggests combining the specific high-shear emulsification and film-coating approach of the present claims.” Respectfully, the Examiner does not agree because Texier-Nogues et al. teach using a sonicator, microfluidizer or high-pressure homogenizer to perform the emulsification, where at least the high-pressure homogenizer achieves a high-shear emulsification, and film forming is suggested. None of Applicant’s arguments are persuasive.
On page 7 of remarks, Applicant further discusses Mwiiri et al. However, the rejection over Mwiiri et al. has been withdrawn.
MPEP 2141 III states: “The proper analysis is whether the claimed invention would have been obvious to one of ordinary skill in the art after consideration of all the facts.” Respectfully, after review of all the facts, Applicant’s arguments are not persuasive. The Examiner has reached a determination that the instant claims are not patentable in view of the preponderance of evidence and consideration of all the facts, which is more convincing than the evidence which has been offered in opposition to it.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERNST V ARNOLD whose telephone number is (571)272-8509. The examiner can normally be reached M-F 7-3:30.
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/ERNST V ARNOLD/Primary Examiner, Art Unit 1613