DETAILED ACTION
In Applicant’s Response filed 6/5/26, Applicant has amended claims 1 and 10; and added new claims 23-32. Claims 2-9, 15-17 and 21 have been cancelled. Currently, claims 1, 10-14, 18-20 and 22-32 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 .
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 25 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 pre-AIA the applicant regards as the invention.
Specifically, claim 25 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for claiming both an apparatus and the method steps of using the apparatus.
Under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph, a single claim which claims both an apparatus and the method steps of using the apparatus is indefinite. See In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303, 1318, 97 USPQ2d 1737, 1748-49 (Fed. Cir. 2011). In Katz, a claim directed to "[a] system with an interface means for providing automated voice messages…to certain of said individual callers, wherein said certain of said individual callers digitally enter data" was determined to be indefinite because the italicized claim limitation is not directed to the system, but rather to actions of the individual callers, which creates confusion as to when direct infringement occurs. Katz, 639 F.3d at 1318 (citing IPXL Holdings v. Amazon.com, Inc., 430 F.3d 1377, 1384, 77 USPQ2d 1140, 1145 (Fed. Cir. 2005), in which a system claim that recited "an input means" and required a user to use the input means was found to be indefinite because it was unclear "whether infringement … occurs when one creates a system that allows the user [to use the input means], or whether infringement occurs when the user actually uses the input means."); Ex parte Lyell, 17 USPQ2d 1548 (Bd. Pat. App. & Inter. 1990) (claim directed to an automatic transmission workstand and the method of using it held ambiguous and properly rejected under 35 U.S.C. 112, second paragraph.
In the present case, the pre-amble of claim 25 is directed to an “article” but the claim includes limitations defining a “Method A” with creates ambiguity with respect to which statutory class of invention is being claimed. Thus, for at least this reason, claim 25 is rendered indefinite. For purposes of examination, the Office has treated claim 25 as being a “product claim” however revision is nevertheless required in order to clarify which statutory class of invention that Applicant intended to claim.
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) and further in view of Lee et al (CN 1305370 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.
Sarasua also does not disclose that less than 50% of the bioactive glass particles are bonded to fibers of the nonwoven matrix.
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 the fibers in the nonwoven material. 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 50% of the bioactive glass particles are bonded to the fibers of the nonwoven matrix, 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(s) 1, 10, 12, 14, 18 and 24 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) and Lee et al (CN 1305370 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.
Lo in view of Sarasua and further in view of SEO 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.
With respect to claim 10, LO in view of Sarasua and further in view of SEO and Lee 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 (para [0105]), directing a stream of bioactive glass particles amidst the filaments or fibers as a separate stream from the molten polymer and after formation of the filaments, and collecting a nonwoven matrix and bioactive glass particles enmeshed in the nonwoven matrix (hemostatic agent may be added by known methods such as by spraying onto the gauze – para [0104] – the spray that includes the particles inherently is separate from molten polymer and is applied to already formed filaments since the material is already in gauze form when sprayed; 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 and Lee 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 and Lee 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).
With respect to claim 18, LO in view of Sarasua and further in view of SEO and Lee discloses the article substantially as claimed (see rejection of claim 10) but LO 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 and Lee 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.
With respect to claim 24, LO in view of Sarasua and further in view of SEO and Lee discloses the article substantially as claimed (see rejection of claim 1) but LO 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 and Lee 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 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), SEO et al (KR-20180056370-A) and Lee et al (CN 1305370 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 and Lee 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 and Lee 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), SEO et al (KR-20180056370-A) and Lee et al (CN 1305370 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 and Lee 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 and Lee 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.
Claim 19 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), SEO et al (KR-20180056370-A) and Lee et al (CN 1305370 A) and further in view of Chang (CN 106310347 A).
With respect to claim 19, LO in view of Sarasua and further in view of SEO and Lee discloses the method substantially as claimed (see rejection of claim 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 method of LO in view of Sarasua and further in view of SEO and Lee 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 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.
Claims 20 and 31 are 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.
With respect to claim 31, LO in view of SEO and further in view of Lee discloses the article substantially as claimed (see rejection of claim 20) and LO further discloses a carrier layer (substrate 440; fig 4) disposed on a major surface of the nonwoven matrix opposing a wound-facing surface of the nonwoven matrix (substrate 420 which comprises the gauze/mesh material with hemostatic agent is mounted on the skin-contacting surface of the substrate 440; fig 4; thus, the substrate 440 is on the surface of substrate 420 that is opposite the wound-facing surface), wherein the carrier layer comprises a release liner, a polymeric film, an absorbent foam, or a combination thereof (substrate 440 can be a plastic member – para [0107]; a plastic member is interpreted as being a polymeric film).
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.
Claim 23 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 Lee (CN 1360625) (hereinafter Lee ‘625).
With respect to claim 23, Sarasua in view of SEO and further in view of Lee discloses the article substantially as claimed (see rejection of claim 1) but does not disclose that the bioactive glass particles comprise 45 weight % SiO2, 24.5 weight % Na20, 24.5 weight % CaO, and 6 weight % P205, based on the total weight of the bioactive glass particles.
Lee ‘625 teaches bioactive glass particles which are non-toxic and act as biocides for viruses and bacteria, but are mild to skin and fabrics and do not cause allergic reactions (translation pg 2) wherein the particles preferably contain 40-60% by weight of SiO2, 10-30% by weight of CaO, 10-35% by weight of Na2O, and 8 wt% P2O5 (translation pg 3). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have used glass particles which comprise 45 weight % SiO2, 24.5 weight % Na20, 24.5 weight % CaO, and 6 weight % P205, as taught by Lee ‘625, as the glass particles in the article of Sarasua in view of SEO and further in view of Lee, 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 and where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art.
Claim 23 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), SEO et al (KR-20180056370-A) and Lee et al (CN 1305370 A) and further in view of Lee (CN 1360625) (hereinafter Lee ‘625).
With respect to claim 23, LO in view of Sarasua and SEO and further in view of Lee discloses the article substantially as claimed (see rejection of claim 1) but does not disclose that the bioactive glass particles comprise 45 weight % SiO2, 24.5 weight % Na20, 24.5 weight % CaO, and 6 weight % P205, based on the total weight of the bioactive glass particles.
Lee ‘625 teaches bioactive glass particles which are non-toxic and act as biocides for viruses and bacteria, but are mild to skin and fabrics and do not cause allergic reactions (translation pg 2) wherein the particles preferably contain 40-60% by weight of SiO2, 10-30% by weight of CaO, 10-35% by weight of Na2O, and 8 wt% P2O5 (translation pg 3). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have used glass particles which comprise 45 weight % SiO2, 24.5 weight % Na20, 24.5 weight % CaO, and 6 weight % P205, as taught by Lee ‘625, as the glass particles in the article of Lo in view of Sarasua and SEO and further in view of Lee, 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 and where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art.
Claims 25 and 27 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), 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 claims 25 and 27, LO in view of Sarasua and further in view of SEO and Lee discloses the article substantially as claimed (see rejection of claim 1) but does not disclose that the article has a pH value from 8 to 11.5 or that the article is capable of releasing one or more calcium ions from the bioactive glass particles wherein the calcium ions are critical to Epithelial Cadherin (e-cadherin), a polypeptide which mediates cell to cell adhesion and recognition, allowing cell migration into a wound bed.
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 interpreted as being “about” a pH of 8-11.5). Furthermore, it is a known human biological process that calcium ions are critical to Epithelial Cadherin (e-cadherin), a polypeptide which mediates cell to cell adhesion and recognition, allowing cell migration into a wound bed. 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 and Lee such that the bioactive glass in the article renders the article capable of releasing calcium ions, wherein the calcium ions are critical to Epithelial Cadherin (e-cadherin), a polypeptide which mediates cell to cell adhesion and recognition, allowing cell migration into a wound bed, and provides a pH value from 8 to 11.5, as taught by Ollila, in order to assist in inhibiting bacteria growth.
Additionally, with respect to claim 25, with respect to the method steps claimed, to the extent that the prior art apparatus meets the structural limitations of the apparatus, as claimed, it is obvious that it will also perform the method steps as claimed. Furthermore, it has been held that where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977); MPEP 2112.01(I). In the present case, since the prior art device of LO in view of Sarasua, SEO and Lee and further in view of Ollila is the same as the device for carrying out the claimed method steps, it is obvious that the device will perform the claimed process and, therefore, the method claimed is considered to be obvious in view of the prior art device.
Claim 26 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), SEO et al (KR-20180056370-A) and Lee et al (CN 1305370 A) and further in view of Hovis et al (US 20030229326).
With respect to claim 26, LO in view of Sarasua and further in view of SEO and Lee discloses the article substantially as claimed (see rejection of claim 1) but does not disclose that the nonwoven matrix comprises meltblown polyolefin fibers.
Hovis, however, teaches an article suitable for use as a wound dressing (abstract) comprising a nonwoven material formed from meltblown polyolefin fibers (para [0029]). Hovis further teaches that use of meltblown polyolefin nonwoven fabrics is preferred for wound care articles and bandages due to the relatively low raw material cost, ease of manufacturing, desirable strength to basis weight ratio and softness (para [0029]). Thus, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have used a nonwoven material formed from meltblown polyolefin fibers, as taught by Hovis, as the nonwoven material in the article of LO in view of Sarasua and SEO and further in view of Lee, in order to lower costs and simplify manufacturing while also providing desirable strength to basis weight ratio and softness in the end product.
Claim 29 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), SEO et al (KR-20180056370-A) and Lee et al (CN 1305370 A) and further in view of Lee (CN 1360625) (hereinafter Lee ‘625).
With respect to claim 29, LO in view of Sarasua and SEO and further in view of Lee discloses the method substantially as claimed (see rejection of claim 10) but does not disclose that the bioactive glass particles comprise 45 weight % SiO2, 24.5 weight % Na20, 24.5 weight % CaO, and 6 weight % P205, based on the total weight of the bioactive glass particles.
Lee ‘625 teaches bioactive glass particles which are non-toxic and act as biocides for viruses and bacteria, but are mild to skin and fabrics and do not cause allergic reactions (translation pg 2) wherein the particles preferably contain 40-60% by weight of SiO2, 10-30% by weight of CaO, 10-35% by weight of Na2O, and 8 wt% P2O5 (translation pg 3). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have used glass particles which comprise 45 weight % SiO2, 24.5 weight % Na20, 24.5 weight % CaO, and 6 weight % P205, as taught by Lee ‘625, as the glass particles in the method of Lo in view of SEO and further in view of Lee, 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 and where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art.
Claim(s) 28 and 30 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) and Lee et al (CN 1305370 A) with extrinsic evidence from Wagner et al (US 3543332).
With respect to claim 28, LO in view of Sarasua and SEO and further in view of Lee discloses the method substantially as claimed (see rejection of claim 10) and Lo further discloses manufacturing the fibers by way of fiber extrusion, fiber spinning, or fiber drawing (para [0105]) wherein, as evidenced by Wagner, such processes involve extruding the molten polymer through a plurality of fine die capillaries as molten filaments into a high velocity heated gas stream which attenuates the filaments to reduce their diameter, and wherein the meltblown fibers are deposited on a collecting surface (see i.e. process described in example I).
With respect to claim 30, LO in view of Sarasua and SEO and further in view of Lee discloses the method substantially as claimed (see rejection of claim 10) and Lo further discloses manufacturing the fibers by way of fiber extrusion, fiber spinning, or fiber drawing (para [0105]) wherein, as evidenced by Wagner, such processes involve directing a stream of high velocity gas to apply the desired attenuating forces to the filament downstream of the extrusion orifice (col 4 lines 51-57). Thus, LO discloses the step of using a high velocity gas stream that attenuates the filaments into fibers.
Claim 32 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 Lee (CN 1360625) (hereinafter Lee ‘625).
With respect to claim 32, LO in view of SEO and further in view of Lee discloses the dressing substantially as claimed (see rejection of claim 20) but LO does not disclose that less than 5% of the bioactive glass particles are bonded to 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 the fibers in the nonwoven material. 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 and further in view of Lee so that less than 5% 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.
LO in view of SEO and further in view of Lee does not, however, disclose that the bioactive glass particles comprise 45 weight % SiO2, 24.5 weight % Na20, 24.5 weight % CaO, and 6 weight % P205, based on the total weight of the bioactive glass particles.
Lee ‘625 teaches bioactive glass particles which are non-toxic and act as biocides for viruses and bacteria, but are mild to skin and fabrics and do not cause allergic reactions (translation pg 2) wherein the particles preferably contain 40-60% by weight of SiO2, 10-30% by weight of CaO, 10-35% by weight of Na2O, and 8 wt% P2O5 (translation pg 3). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have used glass particles which comprise 45 weight % SiO2, 24.5 weight % Na20, 24.5 weight % CaO, and 6 weight % P205, as taught by Lee ‘625, as the glass particles in the article of Lo in view of SEO and further in view of Lee, 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 and where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art.
Response to Amendments/Arguments
Applicant’s amendments and arguments filed 6/5/26 have been fully considered as follows:
Regarding the claim rejections under 35 USC 103, Applicant’s arguments on pages 7-11 of the Response have been fully considered but are rendered moot in view of the new grounds of rejection presented above which were necessitated by Applicant’s amendments to the claims.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/CAITLIN A CARREIRO/Primary Examiner, Art Unit 3786
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