DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Amendments to claims 21-22, 25, 27-31, 34, and 37-38, and the cancellation of claims 26 and 35, in the response filed March 9, 2026, have been entered.
Claims 21-25, 27-34, and 36-40 are currently pending in the above identified 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 21-25, 27-34, and 36-40 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.
Specifically, the limitations “the first and second non-woven fiber compositions are configured to break down into one or more acidic byproducts when applied to a tissue site, and the one or more acidic byproducts are selected from the group consisting of monomers and oligomers comprising: lactic acid, glycolic acid, 6-hydroxycaprpoic acid, 4-hydroxybutyrate, and 2-hydroxyethoxyacetic acid” (claims 21 and 30), “wherein the first non-woven fiber composition to the second non-woven fiber composition ratio ranged from about 10:1 to about 1:10 by weight” (claims 22, 21), “wherein the first and second non-woven fiber compositions are configured to break down into one or more acidic byproducts via hydrolysis” (claim 24, 33), “wherein the one or more acidic byproducts are configured to create an acidic microenvironment configured to improve wound” (claims 25, 34), “wherein the first non-woven fiber composition is configured to break down into one or more acidic byproducts selected from the group consisting of monomers and oligomers comprising lactic acid and glycolic acid” (claims 27, 36), “wherein the second non-woven fiber composition is configured to breakdown into one or more acidic byproducts selected from the group consisting of monomers and oligomers comprising: 6-hydroxycaproic acid and 2-hydroxyethoxyacetic acid” (claims 28, 37), “wherein the second non-woven fiber composition is configured to breakdown into one or more acidic byproducts selected from the group consisting of monomers and oligomers comprising 2-hydroxyethoxyacetic acid” (claims 29, 38), and “wherein the first surface and the second surface have one or more different physical properties” (claim 30).
There is no explicit support for these limitations in the originally filed disclosure. There is no mention of “acidic byproducts”, including the specifically claimed monomers and oligomers, in the originally filed application. There is also no mention of an acidic microenvironment and no mention of the acidic microenvironment performing the claimed functions. The current claim set was filed November 7, 2025 and not part of the originally filed disclosure, filed on October 8, 2025. The originally filed disclosure teaches specific chemical compositions for the first non-woven fiber composition and the second non-woven fiber composition (see para 0012, 0037 of the filed disclosure). The originally filed disclosure also teaches resorbable polymeric material refers to material formed from resorbable polymers that possess the property to breakdown when the material is exposed to conditions that are typical of those present in a post-surgical site into degradation products that can be removed from the site within a period that roughly coincides with the period of post-surgical healing , such as absorbed into the body of the patient (see para 0036). However, there is no teaching that these degradation products are acidic or specifically the ones recited in the claims.
There is no explicit support for “the first non-woven fiber composition to the second non-woven fiber composition ratio ranges from about 10:1 to about 1:10 by weight” in the originally filed disclosure. The originally filed disclosure teaches “[s]uitable ratios of the first fiber composition to the second fiber composition resulting in the non-woven graft material can range from about 10 to 1 to about 1 to 10” (see para 0039 of published application). However, the originally filed disclosure does not specify that the ratio is by weight. Therefore, the amendment introduces new matter.
There is no explicit support for “wherein the first surface and the second surface have one or more different physical properties.” The only discussion in the originally filed disclosure with regards to physical properties is in the example section and specifically with regards to measurements of mesh fiber, pore size, mass, and dimensions (see para 0080-0081 of published application). This does not support the full scope of the amended claim and therefore introduces new matter.
To overcome this rejection, applicant may attempt to demonstrate that the original disclosure establishes that he or she was in possession of the amended claim or modify this limitation to align with the originally filed disclosure, such as to positively recite the fiber compositions and not the degradation products.
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.
Claims 21-25, 27-34, and 36-40 are rejected under 35 U.S.C. 103 as being unpatentable over US Pub. No. 2015/0211151 to Taylor in view of US 2006/0085063 to Shastri and US Pub. No. 2013/0018454 to Lelkes, as evidenced “Less harmful acidic degradation of poly(lactic-co-glycolic acid) bone tissue engineering scaffold through titania nanoparticle addition” to Liu, and “polydioxanone implants: A systematic review on safety and performance in patients” to Martins.
Regarding claims 21-25, 27-34, and 36-40, Taylor teaches a thermally stable electrospun material (fiber matrix), such as a nonwoven fabric, comprising at least two independent fiber population comprising a major fiber component (first non-woven fiber composition) comprising at least one thermally unstable species, specifically a bioabsorbable (resorbable) polyester that is a copolymer of glyoclide and lactide, and a minor fiber component (second non-woven fiber composition) comprising at least one thermally stable species, specifically a bioabsorbable polyether-ester comprising poly(para-dioxanone), that are co-mingled (claim 23, 32) and distributed through the structure of the electrospun material (Taylor, abstract, para 0008-0014, 0050, 0055-0057, 0083-0084). As the electrospun nonwoven materials is formed using biosorbable polymers, the electrospun material reads on a resorbable fiber matrix. Taylor teaches electrospinning produces micro-fibrous materials with a topography similar to the native extracellular matrix (Id., para 0081, 0011), reading on the electrospun material (fiber matrix) having an architecture resembling a native extracellular matrix. Taylor teaches the use of polymers that are degradable by hydrolysis or other biodegradation mechanisms containing monomeric units of lactide, glycolide, ε-caprolactone, and para-dioxanone (Id., para 0055, 0083), reading on the first non-woven fiber composition and second non-woven fiber composition each independently comprising a resorbable polymer and being configured to break down into byproducts, including being configured to break down into byproducts via hydrolysis, specifically 2-hydroxyethoxyacetic acid for poly para-dioxanone (claims 28-29) and lactic acid for polylactide (claim 27), and the electrospun material being a resorbable fiber matrix. Taylor teaches the fibers may range in diameter from 0.1 to 10 micron, more preferably from 0.25 to 5 microns (claim 30) (Id., para 0042). Taylor teaches the pore size being controlled from fabrication and teaches small pores of approximately 10 μm2 and larger pores on the order of 100-2500 μm2 (Taylor, para 0043), reading on the electrospun material (resorbable fiber matrix) comprising a plurality of pores (claim 21) and a plurality of pore comprising a mean pore size of from about 10 to about 2500 μm2 (claim 30). Taylor teaches the mesh or web (fiber matrix) being applied to a treatment site (Id., para 0060) or being formed into medical implants and/or scaffolds for tissue engineering (Id., para 0081), reading on the material being capable of being applied to a tissue site. Taylor teaches the electrospun fabric having a three-dimensional structure with one fiber being predominately present on the exterior of the structure but lacking on the interior (Id., para 0093), reading on a first surface and a second surface and the first surface and the second surface having one or more different physical properties.
Taylor does not explicitly teach the fiber matrix comprising a plurality of protrusion and a plurality of depressions.
However, Shastri teaches a synthetic conduit comprising a substantially tubular body comprising substantially circumferential polymer fiber, including biodegradable polymer fibers that can undergo controlled biodegradation occurring concomitantly with remodeling by the cells of the host subject, such as of polylactic acid, polyglycolic acid, or poly(ε-caprolactone), or a mixture thereof (Shastri, abstract, para 0088-0089). Shastri teaches the conduit being used as a vascular prosthesis, a stent, or a nerve regeneration scaffold (Id., abstract). Shastri teaches the body having microscale features, including reservoirs, protrusion, wells, ridges and/or grooves such on the interior surface (first surface) (Id., abstract, para 0088, 0114-0123), reading on the fiber matrix comprising a plurality of protrusion and a plurality of depressions. Shastri teaches that by creating well-defined micro-textured structure or patterns on a surface, fluid flow at the surface can be altered to create discrete regions of low shear rates that can serve as sanctuaries for endothelial cells and promote their retention (Id., para 0150, 0173-0177, 0218-0219). Shastri teaches cells can be adhered to the exterior and/or interior surface, including muscle sell adhered to the exterior surface (second surface) (Id., para 0014-0019). Lelkes teaches a graft having surface topography, both microchannels and microfiber, and teaches the microscale surface topography directs endothelial cell alignment (Lelkes, abstract, para 0110, 0188), reading on a second surface with a plurality of depressions (channels) in the second surface of the resorbable fiber matrix.
It would have been obvious to one of ordinary skill in the art before the effective filing date to form the electrospun material of Taylor, wherein the material includes the micro-textured structure or pattern of Shastri and Lelkes on an interior surface and exterior surface, motivated by the desire of forming conventionally known structures predictably suitable for use on the surface of fibrous material comprising biodegradable fibers suitable for use in scaffolding or medical implants and by the desire to create discrete regions of low shear rates that can serve as sanctuaries for endothelial cells and promote their retention as well as direct cell alignment.
Regarding the first and second nonwoven fiber composition being configured to break down into one or more acidic byproducts when applied to a tissue site and the one or more acidic byproducts being selected from the group consisting of monomers and oligomers comprising: lactic acid, glycolic acid, 6-hydroxycaprpoic acid, caproic acid, 4-hydroxybutyrate, 2-hydroxyethoxyacetic acid, glyoxylic acid, and oxalic acid (claim 21, 30), specifically the first nonwoven fiber composition breaking down into one or more acidic byproducts selected from the group consisting of monomers and oligomers comprising lactic acid and glycolic acid (claims 27, 36) and the second non-woven fiber breaking down into one or more acidic byproducts selected from the group consisting of monomers and oligomers comprising: 6-hydroxycaproic acid, caproic acid, 2-hydroxyethoxyacetic acid, glyoxylic acid, and oxalic acid (claims 28, 37), more specifically 2-hydroxyethoxyacetic acid (claims 29, 38); the first and second non-woven fiber compositions being configured to break down into one or more acidic byproducts via hydrolysis (claim 24, 30); and the one or more acidic byproducts creating an acidic microenvironment, wherein the acidic microenvironment is configured to perform a function selected from the group consisting of: promote cell growth, promote antimicrobial activity, promote angiogenesis, modulate cellular and pathogenic activity, improve tissue oxygenation, promote epithelialization, promote the proliferation of fibroblasts, and migration of fibroblasts (claims 25, 34), specifically configured to promote cell growth, wherein the cell growth results in granulation tissue formation and/or neovascularization (claims 26, 35), these limitations are directed towards the intended use of the fiber matrix and corresponding properties. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The prior art combination teaches an electrospun nonwoven fabric comprising fibers of a bioabsorbable polyester that is a copolymer of glyoclide and lactide and a bioabsorbable polyether-ester comprising poly(para-dioxanone) that has a topography similar to the native extracellular matrix can be used in medical implants and/or scaffolds for tissue engineering and therefore is capable of being applied to tissue site. Liu teaches poly(lactic-co-glycolic acid) degradation product including lactic acid and/or glycolic acid by hydrolysis (Liu, p. 541), therefore polylactic acid and polyglycolic acid as known to be capable of degrading to lactic acid or glycolic acid, respectively, acidic byproducts as claimed. Martins teaches the polydioxanone is known to have acidic degradation products (Martins, p. 903) and teaches oxalic acid, 2-hydroxyacetic acid, and glyoxylic acid as degradation products (Id., p. 909-910), reading on polydioxanone being capable of breaking down into one or more acidic products, including oxalic acid, 2-hydroxyacetic acid, and glyoxylic acid. The fibers of the prior art combination are formed using the same materials as disclosed in the instant invention and contains the structure as claimed. Products of identical structure and composition cannot have mutually exclusive properties. Absent evidence to contrary, the electrospun material containing the bioabsorbable fibers specifically comprising a copolymer of lactic acid and glycolic acid and polydioxanone would be capable of being used as claimed and having the resultant features in properties, especially in light of the teachings of Liu and Martin. The burden is on the Applicants to prove otherwise.
Regarding claims 22 and 31, the prior art combination teaches the ratio of major to minor component by weight being 85/15 to 50/50 (Taylor, para 0054), reading on the first non-woven fiber composition to the second non-woven fiber composition ratio ranges 5.66:1 to 1:1.
Claims 28-29 and 37-38 are rejected under 35 U.S.C. 103 as being unpatentable over US Pub. No. 2015/0211151 to Taylor in view of US 2006/0085063 to Shastri and US Pub. No. 2013/0018454 to Lelkes, as evidenced “Less harmful acidic degradation of poly(lactic-co-glycolic acid) bone tissue engineering scaffold through titania nanoparticle addition” to Liu, and “polydioxanone implants: A systematic review on safety and performance in patients” to Martins, as applied to claims 21-25, 27-34, and 36-40 above, further in view of US Pub. No. 2003/0236320 to Martin.
Regarding claims 28-29 and 37-38, in the event that the prior art material are not necessarily capable of breaking down into the claimed monomers and oligomers, the prior art combination teaches the fibers comprising polymers such as polyhydroxyalkanoate (Taylor, para 0055). Martin teaches a biocompatible polyhydroxyalkanoate comprising with controlled degradation rate (Martin, abstract). Martin teaches the monomers which can be incorporated into polyhydroxyalkanoate to alter the rate of degradation include 2-hydroxy acid such as 2-hydroxyethoxyacetic acid, which are more susceptible to hydrolytic or enzyme attack (Id., para 0055), reading on being configured to breakdown into one or more acidic byproducts, specifically 2-hydroxyethoxyacetic acid, absent evidence to the contrary.
It would have been obvious to one of ordinary skill in the art before the effective filing date to form the material of the prior art combination, wherein the fiber comprising the polyhydroxyalkanoate comprises 2-hydroxyethoxyacetic acid as taught by Martin, motivated by the desire of using conventionally known biodegradable materials, such as polyhydroxyalkanoate, predictably suitable for use in grafts and by the desire of controlling the degradation rate.
Response to Arguments
Applicant's arguments filed March 9, 2026 have been fully considered but they are not persuasive with regards to the new matter rejection.
Regarding the new matter rejection, Applicant points to the definition of “resorbable polymers” described as “polymers [that] possess the property to break down when the material is exposed to condition that are typical of those present in post-surgical site into degradation products that can be removed from the site within a period that roughly coincides with the period of post-surgical healing” as support for this limitation. Examiner agrees that this portion supports the polymers being capable of breaking down into degradation products. However, the claim is very specific as to the methodology and specific byproducts of the breakdown. The claim also recites the byproducts formed without specifying the starting polymers. Applicant is relying on the recited material being capable of breaking down into the claimed byproduct(s), however, the claim scope would encompass any polymer capable of degrading into the claimed products, which could include materials and polymers beyond those recited in the originally filed disclosure and therefore not originally envisioned. As the originally filed disclosure does not discuss the specific degradation products nor their impact to the healing process beyond their ability to be removed from the site within a period roughly coinciding with the period of post-surgical healing, the claimed scope is beyond the originally envision invention.
Applicant argues that a person of ordinary skill in the art would have understood at the time of filing that the resorbable polymers disclosed in the specification degrade via hydrolysis to form the corresponding acidic degradation products recited in the instant claimed and would understand that these acidic byproducts would create an acidic microenvironment configured to improve would healing as recited in para 0040 of the present application. Examiner respectfully disagrees. Para 0040 of the originally filed disclosure states “[i]n one particularly suitable embodiment, the non-woven graft material is made from a first non-woven fiber composition prepared from poly(lactic-co-glycolic acid) and a second non-woven fiber composition prepared from polydioxanone. The resultant non-woven graft material is a non-biologic tissue substitute designed to provide optimal strength, handling, and suturability, while reducing local inflammation to provide improved wound healing and tissue regeneration.” This portion is specific to a particular embodiment composition the first non-woven fiber composition prepared from poly(lactic-co-glycolic acid) and the second non-woven fiber composition prepared from polydioxanone. The improved wound healing is taught in relation to reduced local inflammation, not acidic byproducts or environment. The concept of acidic byproducts, the creation of an acidic microenvironment, or the acidic microenvironment being configured to improve wound healing is not supported in the originally filed disclosure.
Applicant argues that it is well known in the art at the time the present application was filed that resorbable polymers break down via hydrolysis. Examiner would like to highlight that it is unclear the referenced application filing. Is Applicant arguing an effective filing date of 10/08/2025 or 5/12/2016? The application is listed as a continuation, which indicate an effective filing date of 5/12/2016. The claims previously examined are not original to the application and therefore would not be considered part of the originally filed disclosure and allow a continuation-in-part status as introducing additional concepts. Applicant points to NPL showing certain polymers can degrade into the acidic byproducts claimed. However, these NPL include publication dates of 2019 and 2020, after the effective filing date of 5/12/2016. These later publication dates do not support that a person of ordinary skill in the art before the effective filing date (May 12, 2016) would have known that the degradation would have been hydrolysis and form the specifically claimed acidic monomers. Applicant appears to be using subsequently available knowledge after the effective filing date to redefine their invention after 2020. Additionally, as discussed above, polymers beyond those originally disclosed could be within the scope of the claim. The originally filed disclosure support the specifically recited polymers in paragraphs 0011-0014 of the published application but does not support claiming the degradation polymers based on the undisclosed capability to break down into acidic byproducts.
Therefore, Examiner maintains the new matter rejection detailed above.
Applicant argues, with regards to the application of Taylor of Shastri, that Shastri is silent with regards to the exterior surface having microscale features. Shastri teaches the microtextured structure creating region that serve as sanctuaries for endothelial cells and promote their retention. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to impart microtextured structuring to the surfaces desired for endothelial cell and teaches application of cells to both the interior and exterior surfaces. Lelkes teaches it is known to use microchannels for endothelial cells alignment, reading on depression on a second surface.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNIFER ANN GILLETT whose telephone number is (571)270-0556. The examiner can normally be reached 7 AM- 4:30 PM EST M-H.
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/JENNIFER A GILLETT/Examiner, Art Unit 1789
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