DETAILED ACTION
In Applicant’s amendments filed 1/2/26, Applicant has amended claims 1, 5-7, 10 and 20; and added new claims 21-22. Claims 3 and 15 have been cancelled. Currently, claims 1-2, 4-14 and 16-22 are pending.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 1/2/26 has been entered.
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.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Sarasua et al (WO-2019193053-A1) in view of SEO et al (KR-20180056370-A).
With respect to claim 1, Sarasua et al discloses an article (nonwoven composite article prepared from electrospun fibers – pg 1 lines 4-5), comprising:
a nonwoven matrix (nonwoven composite prepared from electrospun fibers – pg 1 lines 4-5), wherein the nonwoven matrix has an average fiber diameter in the range of 3 to 19 micrometers (very thin fibers can be produced having diameters, usually on the order of about 50 nanometers to about 25 microns – pg 1 lines 27-30); and
bioactive glass particles enmeshed in the nonwoven matrix (the article can include inorganic bioactive particles such as hydroxyapatite or bioactive glasses incorporated into the structure to stimulate cell proliferation – pg 3 lines 23-24; “incorporation” into the nonwoven structure is interpreted as resulting in the particles being enmeshed in the nonwoven material);
wherein the article is a conformable wound dressing (the electrospun fibers are particularly useful in forming non-woven mats suitable for use in wound dressings – pg 1 lines 24-26; the dressing is interpreted as being conformable since it can include a microfibrous structure that provides topography and a nanofibrous structure that promotes high surface area that improves cell adhesion - pg 2 lines 22-28).
Sarasua does not, however, disclose that the bioactive glass particles comprise 10-80 wt% of a total weight of the article.
SEO, however, teaches a medical material that can be in the form of a nonwoven fabric (see claims on pg 1 of translation) which includes biologically active glass particles (abstract) wherein the article comprises 13.5-17 wt% bioactive glass to provide good mechanical properties (experimental example 6; translation pg 11; 13.5-17wt% is within the claimed range of 10-80 wt%; the weight percentages disclosed are interpreted as being a percentage based on the total weight of the article that the particles are incorporated into such as the nonwoven fabric described in page 1 of the translation). Thus, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have configured the article of Sarasua having 10-80 wt% bioactive glass particles, as taught by SEO, in order to provide good mechanical properties.
Claim(s) 1, 4-5, 8-10, 12 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over LO et al (EP-2863961-B1) in view of Sarasua et al (WO-2019193053-A1) and further in view of SEO et al (KR-20180056370-A).
With respect to claim 1, LO discloses an article (hemostatic device – para [0010]), comprising: a nonwoven matrix (gauze substrate can be a nonwoven fibrous material – see para [0079]); and bioactive glass particles (para [0020]) enmeshed in the nonwoven matrix (the hemostatic agent is incorporated into a nonwoven structure to form a gauze – para [0015]; “incorporation” into the nonwoven structure is interpreted as resulting in the particles being enmeshed in the nonwoven material); wherein the article is a conformable wound dressing (see para [0014]).
LO does not, however, disclose that the nonwoven matrix has an average fiber diameter in the range of 3-19 micrometers.
Sarasua et al, however, teaches an article (nonwoven composite article prepared from electrospun fibers – pg 1 lines 4-5), comprising:
a nonwoven matrix (nonwoven composite prepared from electrospun fibers – pg 1 lines 4-5), wherein the nonwoven matrix has an average fiber diameter in the range of 3 to 19 micrometers (very thin fibers can be produced having diameters, usually on the order of about 50 nanometers to about 25 microns – pg 1 lines 27-30); and
bioactive glass particles enmeshed in the nonwoven matrix (the article can include inorganic bioactive particles such as hydroxyapatite or bioactive glasses incorporated into the structure to stimulate cell proliferation – pg 3 lines 23-24; “incorporation” into the nonwoven structure is interpreted as resulting in the particles being enmeshed in the nonwoven material);
wherein the article is a conformable wound dressing (the electrospun fibers are particularly useful in forming non-woven mats suitable for use in wound dressings – pg 1 lines 24-26; the dressing is interpreted as being conformable since it can include a microfibrous structure that provides topography and a nanofibrous structure that promotes high surface area that improves cell adhesion - pg 2 lines 22-28).
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have modified the nonwoven of LO to have an average fiber diameter in the range of 3 to 19 micrometers as taught by Sarasua since the very thin fibers provide a mat with very small interstices and high surface area per unit mass which are two characteristics that are important in determining the porosity of the mat (Sarasua pg 1 lines 26-34).
Lo in view of Sarasua does not, however, disclose that the bioactive glass particles comprise 10-80 wt% of a total weight of the article.
SEO, however, teaches a medical material that can be in the form of a nonwoven fabric (see claims on pg 1 of translation) which includes biologically active glass particles (abstract) wherein the article comprises 13.5-17 wt% bioactive glass to provide good mechanical properties (experimental example 6; translation pg 11; 13.5-17wt% is within the claimed range of 10-80 wt%; the weight percentages disclosed are interpreted as being a percentage based on the total weight of the article that the particles are incorporated into such as the nonwoven fabric described in page 1 of the translation). Thus, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have configured the article of LO in view of Sarasua having 10-80 wt% bioactive glass particles, as taught by SEO, in order to provide good mechanical properties.
With respect to claim 4, LO in view of Sarasua and further in view of SEO discloses the article substantially as claimed (see rejection of claim 1) and LO also discloses that the nonwoven matrix is a nonwoven fibrous web of polymeric fibers (gauze substrate can be a nonwoven fibrous material – see para [0079]; the fibers can comprise polymeric segments – para [0106]).
With respect to claim 5, LO in view of Sarasua and further in view of SEO discloses the article substantially as claimed (see rejection of claim 1) and LO also discloses that a plurality of randomly oriented discrete fibers is entangled to form the nonwoven fibrous web (nonwoven structures can be formed using mechanical bonding techniques which involve entanglement of fibers).
With respect to claim 8, LO in view of Sarasua and further in view of SEO discloses the article substantially as claimed (see rejection of claim 1) and LO also discloses that the article comprises a substrate (para [0010]).
With respect to claim 9, LO in view of Sarasua and further in view of SEO discloses the article substantially as claimed (see rejection of claim 1) and LO also discloses a carrier wherein the nonwoven matrix is disposed on or within the carrier (a release agent in the form of a film may be provided on one side of the substrate – para [0111]).
With respect to claim 10, LO in view of Sarasua and further in view of SEO discloses the article substantially as claimed (see rejection of claim 1) and LO also discloses a method of making the article (para [0104]) including the steps of flowing molten polymer through a plurality of orifices to form the filaments (manufacturing by way of fiber extrusion, fiber spinning, or fiber drawing, etc - para [0105]; fiber extrusion is known to involve forcing molten polymer through orifices to create continuous filaments or fibers), attenuating the filaments into fibers, directing a stream of bioactive glass particles amidst the filaments or fibers, and collecting a nonwoven matrix and bioactive glass particles enmeshed in the nonwoven matrix (hemostatic agent may be added during the substrate fabrication wherein if the substrate is a non-woven gauze material, the hemostatic agent may be incorporated into or onto the fibers by applying the agent to molten material and fibers may be drawn from the material melt – para [0104]; the hemostatic agent is incorporated into the nonwoven structure to form a gauze – para [0015]; “incorporation” into the nonwoven structure is interpreted as resulting in the particles being enmeshed in the nonwoven material with the resulting nonwoven matrix with glass particles being collected after fabrication).
With respect to claim 12, LO in view of Sarasua and further in view of SEO discloses the article substantially as claimed (see rejection of claim 1) and LO also discloses that the nonwoven matrix comprises water soluble fibers, absorbent fibers or elastic fibers (the substrate can be fibrous, nonwoven, and absorbent – para[0036]).
With respect to claim 14, LO in view of Sarasua and further in view of SEO discloses the method substantially as claimed (see rejection of claim 10) and LO also discloses that the molten polymer comprises a polyurethane elastomer, a polybutylene elastomer, a polyester elastomer, a polypropylene/polyethylene, or a hydrogenated styrene isoprene/butadiene styrene block copolymer(s) (see claim 7; page 24).
Claim(s) 2 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over LO et al (EP-2863961-B1) in view of Sarasua et al (WO-2019193053-A1) and SEO et al (KR-20180056370-A) and further in view of Ollila et al (WO 2011/001028).
With respect to claims 2 and 7, LO in view of Sarasua and further in view of SEO discloses the article substantially as claimed (see rejection of claim 1) but does not disclose that the article has a pH value from 5 to 11 or that the article is capable of releasing one or more calcium ions from the bioactive glass particles when contacted with an aqueous environment.
Ollila, however, teaches that bioactive glass is known to release ions such as calcium in aqueous conditions (pg 4 lines 12-14) which elevates pH and osmotic pressure and can inhibit the growth of bacteria especially with respect to anaerobic bacterial species (pg 3 line 24 – pg 4 line 21). Ollila further teaches that use of bioactive glass has been shown to elevate pH such that the optimal pH of all the bacteria tested is close to neutral (see pg 4 lines 14-15; pH of 7 is considered “neutral” and is within the claimed range of 5-11). Thus, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have configured the article of LO in view of Sarasua and further in view of SEO such that the bioactive glass in the article renders the article capable of releasing calcium ions in an aqueous environment and provides a pH value from 5 to 11, as taught by Ollila, in order to assist in inhibiting bacteria growth.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over LO et al (EP-2863961-B1) in view of Sarasua et al (WO-2019193053-A1) and SEO et al (KR-20180056370-A) and further in view of Lee et al (CN 1305370 A).
With respect to claim 6, LO in view of Sarasua and further in view of SEO discloses the article substantially as claimed (see rejection of claim 4) but does not disclose that less than 50% of the bioactive glass particles are bonded to the polymeric fibers.
Lee, however, teaches a nonwoven material with bioactive glass particles which are not connected/fused to the material but, instead, are held in the material by electrostatic forces (translation pg 3). Thus, Lee is interpreted as teaching that 0% of the glass particles are bonded to fibers. It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have formed the article of LO in view of Sarasua and further in view of SEO so that less than 50% of the bioactive glass particles are bonded to the polymeric fibers, like the nonwoven material of Lee, in order to increase flexibility of the structure and movement of the bioactive glass particles throughout the material.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over LO et al (EP-2863961-B1) in view of Sarasua et al (WO-2019193053-A1) and SEO et al (KR-20180056370-A) and further in view of Day et al (US 2014/0180434).
With respect to claim 11, LO in view of Sarasua and further in view of SEO discloses the method substantially as claimed (see rejection of claim 10) but does not disclose the step of meltblowing the filaments.
Day, however, teaches a scaffold that includes glass microspheres (such as bioactive glass beads 140 – example in para [0048]) distributed throughout the scaffold (abstract) wherein the scaffold is “a nonwoven fabric made via a spunlaid or spun blown process, a melt blown process, a wet laid matt or `glass tissue` process, or the like and may be formed to have the characteristics of a felt, a gauze, a cotton ball, cotton candy, or the like” (para [0030]). Thus, Day teaches the step of meltblowing filaments used in the nonwoven fabric. Day further teaches that such methods are used in order to provide an interlinking, partially interlocking, entangled, and/or specifically orientated three-dimensional fiber construct (para [0030]). Thus, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have modified the method of LO in view of Sarasua and further in view of SEO to include the step of meltblowing the filaments, as taught by Day, in order provide an interlinking, partially interlocking, entangled, and/or specifically orientated three-dimensional fiber construct which will be suitable for accommodating the bioactive glass particles therein.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over LO et al (EP-2863961-B1) in view of Sarasua et al (WO-2019193053-A1) and SEO et al (KR-20180056370-A) and further in view of Wilcher et al (US 2007/0154510).
With respect to claim 13, LO in view of Sarasua and further in view of SEO discloses the article substantially as claimed (see rejection of claim 1) but does not disclose that the nonwoven matrix comprises polyolefin fibers.
Wilcher, however, teaches a carrier configured to be applied to a wound (para [0016]) which includes bioactive glass incorporated into the material (para [0029]) wherein the carrier can be a nonwoven fibrous article prepared using fibers such as polyolefin (para [0016;0018]). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have formed the nonwoven matrix of LO in view of Sarasua and further in view of SEO from polyolefin fibers, like the nonwoven matrix of Wilcher, since it is within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice.
Claims 16 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over LO et al (EP-2863961-B1) in view of Sarasua et al (WO-2019193053-A1) and SEO et al (KR-20180056370-A) and further in view of Chang (CN 106310347 A).
With respect to claims 16 and 19, LO in view of Sarasua and further in view of SEO discloses the article substantially as claimed (see rejection of claims 1 and 10) but does not disclose that the bioactive glass particles comprise one or more of boron, magnesium or zinc.
Chang, however, teaches a wound dressing which includes bioactive glass to promote wound healing wherein the bioactive glass may be doped with magnesium, potassium and zinc (translation pg 3). Thus, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have modified the device of LO in view of Sarasua and further in view of SEO so that the bioactive glass particles comprise one or more of boron, magnesium or zinc, as taught by Chang, in order to promote wound healing and, furthermore, because it is within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over LO et al (EP-2863961-B1) in view of Sarasua et al (WO-2019193053-A1) and SEO et al (KR-20180056370-A) and further in view of Asculai (WO 2008/031194).
With respect to claim 17, LO in view of Sarasua and further in view of SEO discloses the article substantially as claimed (see rejection of claim 10) but does not disclose that the bioactive glass particles comprise at least one of sodium or phosphorus.
Asculai, however, teaches use of bioactive glass particles for skin treatment since “finely grained powders of bioactive glasses have substantial anti-microbial, anti-inflammatory and mineralizing properties” and “are suited to function as active ingredients for use in a broad variety of cosmetic and personal care products” wherein “bioactive glasses are typically composed of oxides of silicon, calcium, sodium and phosphorus” (pg 10 lines 12-20). Thus, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have modified the device of LO in view of Sarasua and further in view of SEO so that the bioactive glass particles comprise sodium or phosphorus, as taught by Asculai, in order to provide anti-microbial, anti-inflammatory and mineralizing properties and, furthermore, because it is within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over LO et al (EP-2863961-B1) in view of Sarasua et al (WO-2019193053-A1) and SEO et al (KR-20180056370-A) and further in view of Lee et al (CN 1305370 A).
With respect to claim 18, LO in view of Sarasua and further in view of SEO discloses the article substantially as claimed (see rejection of claim 10) but does not disclose that less than 10% of the bioactive glass particles are bonded to the fibers.
Lee, however, teaches a nonwoven material with bioactive glass particles which are not connected/fused to the material but, instead, are held in the material by electrostatic forces (translation pg 3). Thus, Lee is interpreted as teaching that 0% of the glass particles are bonded to fibers. It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have formed the article of LO in view of Sarasua and further in view of SEO so that less than 10% of the bioactive glass particles are bonded to the fibers, like the nonwoven material of Lee, in order to increase flexibility of the structure and movement of the bioactive glass particles throughout the material.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Sarasua et al (WO-2019193053-A1) in view of SEO et al (KR-20180056370-A) and further in view of Lee et al (CN 1305370 A).
With respect to claim 20, Sarasua et al discloses an article (nonwoven composite article prepared from electrospun fibers – pg 1 lines 4-5) wherein the article is a conformable wound dressing (the electrospun fibers are particularly useful in forming non-woven mats suitable for use in wound dressings – pg 1 lines 24-26; the dressing is interpreted as being conformable since it can include a microfibrous structure that provides topography and a nanofibrous structure that promotes high surface area that improves cell adhesion - pg 2 lines 22-28), comprising:
a nonwoven matrix (nonwoven composite prepared from electrospun fibers – pg 1 lines 4-5) wherein the nonwoven matrix is a nonwoven fibrous web of polymeric fibers (nonwoven structures inherently are constructed as a fibrous web of fibers; wound dressings are formed using non-woven mats of polymeric fibers – pg 2 lines 1-5), and
bioactive glass particles enmeshed in the nonwoven matrix (the article can include inorganic bioactive particles such as hydroxyapatite or bioactive glasses incorporated into the structure to stimulate cell proliferation – pg 3 lines 23-24; “incorporation” into the nonwoven structure is interpreted as resulting in the particles being enmeshed in the nonwoven material).
Sarasua does not, however, disclose that the bioactive glass particles comprise 10-80 wt% of a total weight of the article.
SEO, however, teaches a medical material that can be in the form of a nonwoven fabric (see claims on pg 1 of translation) which includes biologically active glass particles (abstract) wherein the article comprises 13.5-17 wt% bioactive glass to provide good mechanical properties (experimental example 6; translation pg 11; 13.5-17wt% is within the claimed range of 10-80 wt%; the weight percentages disclosed are interpreted as being a percentage based on the total weight of the article that the particles are incorporated into such as the nonwoven fabric described in page 1 of the translation). Thus, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have configured the article of Sarasua having 10-80 wt% bioactive glass particles, as taught by SEO, in order to provide good mechanical properties.
Sarasua also does not disclose that less than 10% of the bioactive glass particles are bonded to the fibers.
Lee, however, teaches a nonwoven material with bioactive glass particles which are not connected/fused to the material but, instead, are held in the material by electrostatic forces (translation pg 3). Thus, Lee is interpreted as teaching that 0% of the glass particles are bonded to fibers. It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have formed the article of Sarasua in view of SEO so that less than 10% of the bioactive glass particles are bonded to the fibers, like the nonwoven material of Lee, in order to increase flexibility of the structure and movement of the bioactive glass particles throughout the material.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over LO et al (EP-2863961-B1) in view of SEO et al (KR-20180056370-A) and further in view of Lee et al (CN 1305370 A).
With respect to claim 20, LO discloses an article (hemostatic device – para [0010]) wherein the article is a conformable wound dressing (see para [0014]), comprising: a nonwoven matrix (gauze substrate can be a nonwoven fibrous material – see para [0079]) wherein the nonwoven matrix is a nonwoven fibrous web of polymeric fibers (nonwoven structures inherently are constructed as a fibrous web of fibers; the fibers used comprise polymeric segments and thus are polymeric fibers – see para [0106]); and bioactive glass particles (para [0020]) enmeshed in the nonwoven matrix (the hemostatic agent is incorporated into a nonwoven structure to form a gauze – para [0015]; “incorporation” into the nonwoven structure is interpreted as resulting in the particles being enmeshed in the nonwoven material).
LO does not, however, disclose that the article comprises 10-80 wt% bioactive glass particles.
SEO, however, teaches a medical material that can be in the form of a nonwoven fabric (see claims on pg 1 of translation) which includes biologically active glass particles (abstract) wherein the article comprises 13.5-17 wt% bioactive glass to provide good mechanical properties (experimental example 6; translation pg 11; 13.5-17wt% is within the claimed range of 10-80 wt%). Thus, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have configured the article of LO having 10-80 wt% bioactive glass particles, as taught by SEO, in order to provide good mechanical properties.
LO also does not disclose that less than 10% of the bioactive glass particles are bonded to the fibers.
Lee, however, teaches a nonwoven material with bioactive glass particles which are not connected/fused to the material but, instead, are held in the material by electrostatic forces (translation pg 3). Thus, Lee is interpreted as teaching that 0% of the glass particles are bonded to fibers. It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have formed the article of LO in view of SEO so that less than 10% of the bioactive glass particles are bonded to the fibers, like the nonwoven material of Lee, in order to increase flexibility of the structure and movement of the bioactive glass particles throughout the material.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Sarasua et al (WO-2019193053-A1) in view of SEO et al (KR-20180056370-A) and Lee et al (CN 1305370 A) and further in view of Cettina et al (US 2019/0099295).
With respect to claim 21, Sarasua in view of SEO and further in view of Lee discloses the article substantially as claimed (see rejection of claim 20) but does not disclose that the nonwoven matrix has a basis weight in a range of 200-500 grams per square meter.
Cettina, however, teaches a wound dressing that comprises a nonwoven substrate having a basis weight of from about 50 gsm to about 200 gsm (see claim 4; range of 50-200gsm overlaps with claimed range of 200-500gsm). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to configure the nonwoven matrix of Sarasua in view of SEO and further in view of Lee so that the basis weight is within the specific range of 200-500 grams per square meter, as taught by Cettina, in order to provide optimal durability, strength and flexibility for the intended use as a wound dressing and, furthermore, because discovering the optimum or workable ranges involves only routine skill in the art.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over LO et al (EP-2863961-B1) in view of SEO et al (KR-20180056370-A) and Lee et al (CN 1305370 A) and further in view of Cettina et al (US 2019/0099295).
With respect to claim 21, LO in view of SEO and further in view of Lee discloses the article substantially as claimed (see rejection of claim 20) but does not disclose that the nonwoven matrix has a basis weight in a range of 200-500 grams per square meter.
Cettina, however, teaches a wound dressing that comprises a nonwoven substrate having a basis weight of from about 50 gsm to about 200 gsm (see claim 4; range of 50-200gsm overlaps with claimed range of 200-500gsm). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to configure the nonwoven matrix of LO in view of SEO and further in view of Lee so that the basis weight is within the specific range of 200-500 grams per square meter, as taught by Cettina, in order to provide optimal durability, strength and flexibility for the intended use as a wound dressing and, furthermore, because discovering the optimum or workable ranges involves only routine skill in the art.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Sarasua et al (WO-2019193053-A1) in view of SEO et al (KR-20180056370-A) and Lee et al (CN 1305370 A) and further in view of Ollila et al (WO 2011/001028).
With respect to claim 22, Sarasua in view of SEO and further in view of Lee discloses the article substantially as claimed (see rejection of claim 20) but does not disclose that the article is capable of releasing one or more calcium ions from the bioactive glass particles.
Ollila, however, teaches that bioactive glass is known to release ions such as calcium which elevates pH and osmotic pressure and can inhibit the growth of bacteria especially with respect to anaerobic bacterial species (pg 3 line 24 – pg 4 line 21). Thus, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have configured the article of Sarasua in view of SEO and further in view of Lee such that the bioactive glass in the article renders the article capable of releasing ion, including calcium ion, as taught by Ollila, in order to assist in inhibiting bacteria growth.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over LO et al (EP-2863961-B1) in view of SEO et al (KR-20180056370-A) and Lee et al (CN 1305370 A) and further in view of Ollila et al (WO 2011/001028).
With respect to claim 22, LO in view of SEO and further in view of Lee discloses the article substantially as claimed (see rejection of claim 20) but does not disclose that the article is capable of releasing one or more calcium ions from the bioactive glass particles.
Ollila, however, teaches that bioactive glass is known to release ions such as calcium which elevates pH and osmotic pressure and can inhibit the growth of bacteria especially with respect to anaerobic bacterial species (pg 3 line 24 – pg 4 line 21). Thus, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have configured the article of LO in view of SEO and further in view of Lee such that the bioactive glass in the article renders the article capable of releasing ion, including calcium ion, as taught by Ollila, in order to assist in inhibiting bacteria growth.
Response to Amendments/Arguments
Applicant’s amendments and arguments filed 1/2/26 have been fully considered as follows:
Regarding the claim rejections under 35 USC 102, Applicant’s amendments to claim 1 have been fully considered and are sufficient to overcome this rejection which, accordingly, has been withdrawn. New rejections have been made under 35 USC 103, however, as necessitated by Applicant’s amendments to the claims.
Regarding the claim rejections under 35 USC 103, Applicant’s arguments on pages 6-10 of the Response have been fully considered but are not persuasive.
Specifically, the Office has noted Applicant’s arguments on page 7 that the SEO reference is not combinable with the applied references (LO and Sarasua) because SEO is directed to dense, sintered glass ceramics for use in rigid orthopedic implants, not to flexible nonwoven wound dressings and thus does not address structural integration of bioactive glass into a fiber-based matrix. The Office is not persuaded by these arguments, however, because SEO teaches a medical material that can be in the form of a nonwoven fabric (see claims on pg 1 of translation) which includes biologically active glass particles (abstract). Thus, the SEO is interpreted as being directed to incorporation of bioactive glass particles into a nonwoven matrix as recited in claim 1.
The Office has also noted Applicant’s arguments on page 8 that the prior art differs from the invention recited in claim 20 because the LO reference teaches away from a structure in which the majority of particles are not bonded to the fibers because LO is directed to hemostatic dressings in which particulate agents are intentionally retained on or within a substrate using a cross-linked calcium alginate binder-a design that promotes strong particle adhesion to the substrate fibers and because SARASUA does not disclose any particular weight percentage of bioactive glass in a nonwoven matrix, nor does it address particle bonding relationships. The Office is not persuaded by these arguments, however, because the Lee and SEO references have been cited as teaching these claimed features (see rejection of claim 20). In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Therefore, for at least this reason, Applicant’s arguments with respect to the LO and Sarasua references are not persuasive.
The Office has also noted Applicant’s arguments on page 8 that the Lee reference does not disclose a nonwoven matrix because it is directed to topical pharmaceutical compositions for treating inflammatory skin conditions, in which bioactive glass particles are dispersed in creams, gels, ointments, or lotions and applied to intact skin. The Office respectfully disagrees because page 3 of the translation appears to describe a nonwoven material with bioactive glass particles which are not connected/fused to the material but, instead, are held in the material by electrostatic forces – thus, for at least this reason, the Office is not persuaded by Applicant’s argument.
The Office has also noted Applicant’s arguments on pages 8-9 regarding the SEO reference but for at least the same reasons as provided above, the Office is not persuaded by these arguments.
The Office has also noted Applicant’s arguments on pages 9-10 that “the recited 10-80 wt% refers to the amount of bioactive glass relative to the total weight of the article (i.e., the combined weight of the matrix and the particles), not to the internal chemical composition of the glass itself. SEO's discussion of component percentages pertains to the formulation of the glass material, not to its distribution within a dressing article”. The Office is not persuaded by this argument and has clarified in the claim rejections provided above that the weight percentages disclosed in SEO have been interpreted as being a percentage based on the total weight of the article that the particles are incorporated into, such as the nonwoven fabric described on page 1 of the translation. Thus, SEO has been interpreted as teaching that the wt% is of bioactive glass particles that are within a nonwoven medial fabric. For at least this reason, the Office is not persuaded by this argument.
For at least the reasons provided above, the Office is not persuaded by Applicant’s arguments and, therefore, maintains that the prior art of record reads on the claims substantially as recited in the present application.
Conclusion
The following prior art made of record and not relied upon is considered pertinent to applicant's disclosure: YLI-URPO et al (EP-1611906-A1).
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/CAITLIN A CARREIRO/Primary Examiner, Art Unit 3786