DETAILED ACTION
Claims 1-11, 16, 19-26 are currently pending. Claims 1-7, 16, 19-26 are currently under examination.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 01/27/2026 has been entered.
Examiner’s Note
Applicant's amendments and arguments filed 01/27/2026 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. In the Applicant’s response, filed 01/27/2026, it is noted that claims 1 and 11 have been amended. Claims 25-26 are newly added. No new matter or claims have been added.
Modified Rejection:
The following rejection is modified based on Applicant’s claim amendments.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-7, 16, 19, 21-23 and 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2019/106473 (Applicant provided, previously applied) in view of US 2010/136131 (previously applied) and CN 104120500 (Applicant provided, previously applied).
Regarding claims 1 and 3, the limitation of an article comprising a conformable matrix comprising collagen wherein the article is conformable wound dressing is met by the ‘473 publication teaching fibrin and collagen to form a mixture including collagen and fibrin (abstract). The composition is taught to be in the form of a sheet (page 1, Figure 1) or a gel (page 2, lines 5-15). The composition is taught to cause healing in dermal tissue (page 4, lines 5-20) and wound articles (title). The collagen fibrin gel before dehydrate comprises 0.4 to 5 wt% fibrin and 0.6 wt% collagen. After dehydrate the collagen fibrin gel composition comprises at least 0.1, 20, 30, 45, 50 wt% collagen or fibrin and typically not greater than 99 wt% (page 5, lines 30-40).
The limitation of wherein the conformable matrix has a conductivity of less than 3, less than 1.4 millisiemens per centimeter (mS/cm) when immersed in distilled water is met by the ‘473 publication teaching the conductivity determined by method a solution containing 1% w/w collagen-fibrin hydrogel composition described herein may be less than 7, 6, 1 mS/cm. The water was maintained at 25 degrees C immersed in water for at least 10 minutes, the conductivity of the water was measured using mS/cm using a conductivity meter (page 7, lines 1-10), thus teaching a range of conductivity overlapping with the instant claim. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claims 2 and 16, the limitation of wherein the article comprises a substrate is met by the ‘473 publication teaching a release liner (page 8, lines 15-20).
Regarding claim 4, the limitation of wherein the conformable matrix is disposed on or within a carrier is met by the ‘473 publication teaching the composition additionally include fibrinogen (abstract).
Regarding claim 6, the limitation of wherein the conformable matrix further comprises glycerol is met by the ‘473 publication teaching the composition comprises glycerol (page 14, example 10).
Regarding claim 7, the limitation of wherein the conformable matrix is a gel, sponge, scaffold, foam or film is met by the ‘473 publication teaching the composition is taught to be in the form of a sheet (page 1, Figure 1) or a gel (page 2, lines 5-15).
Regarding claim 21, the limitation of wherein the conformable matrix comprises a porous mixture of collagen is met by the ‘473 publication teaching a porous matrix (example 7).
Regarding claim 23, the limitation of wherein the collagen is obtained from a non-fish animal source is met by the ‘473 publication teaching any suitable source of collagen can be used including human, bovine, porcine or other animal sources (page 2, lines 15-25).
Regarding claim 26, the limitation of wherein the conformable matrix has at thickness of between about 5mm and about 10mm is met by the ‘473 publication teaching the article typically have a thickness of at least 10 um and typically no greater than 5mm (page 7, lines 30-37). The instant claims overlap at 5 mm and additionally the instant claims use about language allowing for amount above and below the claim 5mm. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
The ‘473 publication does not specifically teach greater than 20 wt% bioactive glass, wherein the bioactive glass includes between 10 wt% and 75% B2O3 (claim 1) wherein the bioactive glass further comprises one or more of SiO2, Na2O, CaO or P2O5 (claim 22).
The ‘473 publication does not specifically teach wherein the conformable matrix has a pH value more than 5 (claim 5) between 6.5 and 10 when immersed in distilled water at 25 degrees Celsius for 24 hours at a concentration of 10 milligrams per milliliter (claim 19).
The ‘131 publication teaching a composite material of fibrinogen and bioactive glass to be used as a wound dressing (abstract). The bioactive glass can be formulated to incorporate fibrinogen onto the surface of the bioactive glass particles (powder) or a 3-dimensional (3-D) structures [0024]. The matrix is taught to be a cellular component which is collagen ([0032], claim 1 and 8). The device is taught to be a wound dressing ([0065], [0071]). The ‘131 publication teaches application of fibrinogen containing bandage to the wound [0072], thus teaching conformability in application to the wound, absent a clear definition. The composition comprising a composite material and a pharmaceutically acceptable carrier [0053] comprising glycerol [0056]. The ‘131 publication teaching a wound dressing (abstract) and form a 3-dimentionsal solid (claim 13), which reads on film or scaffold absent a clear definition. Porous bioactive glasses can be formulated to incorporate fibrinogen onto the surface of the bioactive glass. The resulting material is able to stimulate fibroblast, endothelial cell, keratinocyte, myofibroblast and mesenchymal stem cell growth, and enable the controlled delivery of fibrinogen to the site of required activity [0024]. The bioactive glass is taught to comprise silicon dioxide, sodium oxide, calcium oxide and phosphorus oxide (claim 10), reading on claim 22. The preferred range of B2O3 is from 0 to about 10% by weight [0038]. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
The ‘500 publication teaches a membrane formed of fish collagen/mesoporous bioglass composite nanofiber membrane. The method comprises preparing a mesoporous bioglass gel, fully mixing a fish collagen solution with the mesoporous bioglass gel and preparing out electrostatic spinning. Mechanical properties of a material, has antibiotic and degradable properties, and has a wide application prospect in the biomedical field, like wound restoration (abstract). The composite is taught to be nanofibers used for wound repair with the desired mechanical properties ([0009], [0057]) wherein flexibility is taught as desired for nanofiber compositions [007]. Thus optimization of the biomechanical properties to include a flexible membrane would be obvious to one of ordinary skill in the art before the filing date of the claimed invention. The ‘500 publication teaches adjusting the pH value to 1-6 [0034]. The ‘500 publication teaches 30-5:1 collagen to mesoporous bioglass blend. The bioglass is taught to be present in a range [0052], and thus an optimizable parameter.
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of claimed invention to include bioactive glass as taught by the ‘131 publication into the wound material as taught by the ‘473 publication because the ‘473 publication teaches a wound material and the ‘131 publication is directed to material to be used with wounds. One of ordinary skill in the art before the filing date of the claimed invention would be motivated to include bioactive glass as taught by the ‘131 publication in the composition taught by the ‘473 publication because the ‘131 publication teaches bioactive glass being known to stimulate fibroblast, endothelial cell, keratinocyte, myofibroblast and mesenchymal stem cell growth, and enable the controlled delivery of fibrinogen to the site of required activity useful in wound healing. One of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success including bioglass as taught by the ‘131 publication into the wound composition taught by the ‘473 publication because the ‘473 publication and the ‘131 publication are both directed to wound care composition containing fibrin and collagen.
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use known pH ranges and known concentrations of bioglass in the wound dressing taught by the combination of the ‘473 publication and the ‘131 publication because the ‘473 publication and the ‘131 publication are directed to wound dressing comprising fibrin/fibrinogen, collagen and bioactive glass and the ‘500 publication teaches collagen bioglass composite membrane used for wound repair. It would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to use known concentrations of bioactive glass and pH for the compositions taught by the combination of the ‘473 publication and the ‘131 publication and the ‘500 publication are directed to wound care compositions containing overlapping ingredients, thus it would have been prima facie obvious to one of ordinary skill in the art to use known amounts taught by the ‘500 publication and optimize to obtain the desired wound dressing. As MPEP 2144.05 recites “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine optimization”.
Regarding the bioactive glass concentration of greater than 20 wt% bioactive glass is met by the ‘473 publication teaching the collagen fibrin gel before dehydrate comprises 0.4 to 5 wt% fibrin and 0.6 wt% collagen. After dehydrate the collagen fibrin gel composition comprises at least 0.1, 20, 30, 45, 50 wt% collagen or fibrin and typically not greater than 99 wt% (page 5, lines 30-40). And the ‘500 publication teaching 30-5:1 collagen to mesoporous bioglass blend. The bioglass is taught to be present in a range [0052], and thus an optimizable parameter. It would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to use a known ratio of bioactive glass to collagen as taught by the combination of ‘473 publication and the ‘500 publication and optimize to obtain the desired collagen/bioactive glass compositions.
That being said and in lieu of objective evidence of unexpected results, the amount of bioactive glass can be viewed as a variable which achieves the recognized result of successfully treating a specific patient for wound healing. The optimum or workable range of dosing can be accordingly characterized as routine optimization and experimentation (see MPEP 2144.05 (II)B). “[Discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” In re Boesch, 617 F.2d 272, 276 (CCPA 1980). Appellants provide no evidence of any secondary consideration such as unexpected results that would render the optimized amounts of dosage nonobvious.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2019/106473 in view of US 2010/136131 and CN 104120500 as applied to claims 1-7, 16, 19, 21-23 and 26 above, and further in view of US 5,399,361 (previously applied).
As mentioned in the above 103(a) rejection, all of the limitations of claims 1-7, 16, 19, 21-23 and 26 are taught by the combination of the ‘473 publication, the ‘131 publication and the ‘500 publication.
The combination of references does not specifically teach wherein the conformable matrix comprises glycerol in an amount of 0.01 to 1 weight % (claim 20).
The ‘361 patent teaches collagen containing sponges for enhancing wound healing (abstract). Suitable plasticizers are taught to include glycerol present at 0 to about 100 wt% (column 4, lines 5-20).
It would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to include glycerol in the concentrations taught by the ‘361 publication as the ‘473 publication and the ‘131 publication teaches the composition to include glycerol wherein plasticizers are included in the composition (page 4) and the ‘361 patent teaches a known range of plasticizers to be used in collagen containing compositions. It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use known concentrations of glycerol collagen containing compositions used on wounds for the collagen containing compositions to be used on wounds taught by the ‘473 publication. As MPEP 2144.05 recites “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine optimization”.
Claim(s) 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2019/106473 in view of US 2010/136131 and CN 104120500 as applied to claims 1-7, 16, 19, 21-23 and 26 above, and further in view of US 2018/0353654 (previously applied).
As mentioned in the above 103(a) rejection, all of the limitations of claims 1-7, 16, 19, 21-23 and 26 are taught by the combination of the ‘473 publication, the ‘131 publication and the ‘500 publication.
The combination of references does not specifically teach the conformable matrix has a viscosity of greater than 500 centipoise (cP) at a shear rate of 1 s-1 (claim 24).
The ‘654 publication teaches an implant configured to fit at or near a bone defect to promote bone growth. The implant can contain an acellular porcine collagen in the amount of 5-25 wt% of the implant (abstract). The matrix is taught to be malleable, cohesive, flowable and/or can be shaped into any shape [0070]. The implant may be wetted or hydrated with a variety of fluids to form a malleable and moldable implant or a slurry that can be subsequently lyophilized [0129]. The moldable implant has a viscosity in the range of 1 to 2000 centipoise and may comprise porcine collagen [0135]. The implant may comprise bioactive glass ([0178]-[0179]).
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use the viscosity taught by the ‘654 publication in the implant taught by the combination of references as the ‘473 publication teaches the composition to be moldable (page 7, lines 25-35) and the ‘657 publication teaches a moldable implant with a wide range of viscosities. One of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success as the combination of the ‘500 publication and the ‘131 publication and the ‘654 publication are both directed to compositions comprising collagen and bioactive glass. One of ordinary skill in the art would be motivated to use the range of viscosity taught by the ‘654 publication and optimize to obtain the desired viscosity as the ‘654 publication teaches a wide range of viscosity used in moldable implants wherein fluids are used to form a malleable implant and the ‘500 publication teaches hydrating the collagen containing compositions (page 7, lines 25-35). As MPEP 2144.05 recites “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine optimization”.
New Rejection:
The following rejections are newly applied based on Applicant’s claim amendments and newly added claims.
Claim(s) 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2019/106473 in view of US 2010/136131 and CN 104120500 as applied to claims 1-7, 16, 19, 21-23 and 26 above, and further in view of US 2014/0231291.
As mentioned in the above 103(a) rejection, all of the limitations of claims 1-7, 16, 19, 21-23 and 26 are taught by the combination of the ‘473 publication, the ‘131 publication and the ‘500 publication.
The combination of references does not specifically teach the B2O3 is between 50 wt% and 75 wt% (claim 25).
The ‘291 publication teaching products including bioactive glass and collagen (abstract) wherein the paste is freeze-dried to form a composite [0006]. The strip may bend and flex [0190]. The 60-90 wt% bioactive glass [0010] the strip may include 85-97 wt% bioactive glass and 3-15 wt% collagen [0013]. B2O3 may be present in the bioactive glass from 0-75 wt% [0038] wherein 45S5B1 is wherein B2O3 replaces SiO2 in the bioactive glass, leading to 46.1% [0037] from 45S5 bioactive glass. As MPEP 2144.05 recites “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine optimization”. The ‘291 publication teaches the ingredients and bendable structure, and thus would be capable of use as a wound dressing, absent factual evidence to the contrary.
It would have been obvious to one of ordinary skill in the art to substitute a first bioactive glass as taught by the ‘131 publication with a second bioactive glass, 45S5B1, as taught by the ‘291 publication with a reasonable expectation of success because the simple substitution of one known element for another would have yielded predictable results to one of ordinary skill in the art at the time of the invention. M.P.E.P. §2144.07 states "The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).” When substituting equivalents known in the prior art for the same purpose, an express suggestion to substitute one equivalent component or process for another is not necessary to render such substitution obvious. In re Fout, 675 F.2d 297, 213 USPQ 532 (CCPA 1982). M.P.E.P. §2144.06. One of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success as the ‘131 publication teaches the bioactive glass may be 45S5 and the ‘291 publication teaches the interchangeability of 45S5 and 45S5B1, wherein the ‘291 publication teaches a range of B2O3 may be used. One of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success as the ‘291 publication and the combination of the 473 publication and the ‘131 publication are directed to collagen bioactive glass matrixes.
Claim(s) 1, 3, 5, 7, 19, 21-23 and 25-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2014/0231291.
Regarding claims 1, 3 and 25, the limitation of an article comprising, a conformable matrix comprising at mixture of collagen and bioactive glass, wherein the conformable matrix comprises a greater than 20 weight percent bioactive glass, wherein the bioactive glass includes between 10 wt%-75 wt% B2O3, wherein the article is conformable wound dressing is met by the ‘291 publication teaching products including bioactive glass and collagen (abstract) wherein the paste is freeze-dried to form a composite [0006]. The strip may bend and flex [0190]. The 60-90 wt% bioactive glass [0010] the strip may include 85-97 wt% bioactive glass and 3-15 wt% collagen [0013]. B2O3 may be present in the bioactive glass from 0-75 wt% [0038] wherein 45S5B1 is wherein B2O3 replaces SiO2 in the bioactive glass, leading to 46.1% [0037]. As MPEP 2144.05 recites “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine optimization”. The ‘291 publication teaches the ingredients and bendable structure, and thus would be capable of use as a wound dressing, absent factual evidence to the contrary.
The limitation of wherein the confirmable matrix has a conductivity of less than 2 millisiemens per centimeter (mS/cm) when immersed in distilled water at 25 degrees C for 16 hours at a concentration of 10 milligrams per milliliter is met by the ‘291 publication teaching the claimed structure comprising overlapping amounts of bioactive glass, B2O3 and comprises collagen in a formable matrix and thus would have the functional feature of conductivity, absent factual evidence to the contrary. “Products of identical chemical composition can not have mutually exclusive properties.” A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Regarding claims 5 and 19, the limitation of wherein the conformable matrix has a pH value more than 5 is met by the ‘291 publication teaching the glass has a pH of 6.5 [0096] wherein the pH is taught as adjustable [040] and thus optimizable.
Regarding claim 7, the limitation of wherein the conformable matrix is a gel, sponge, scaffold foam or film is met by the ‘291 publication teaching a strip [0013].
Regarding claim 21, the limitation of wherein conformable matrix comprises a porous mixture of collagen and bioactive glass is met by the ‘291 publication teaching the use of porous bioactive glass wherein the composite is porous [0013].
Regarding claim 22, the limitation of wherein the bioactive glass further comprises one or more of SiO2, Na2O, CaO or P2O3 is met by the ‘291 publication teaching one or more of SiO2, Na2O, CaO [0089].
Regarding claim 23, the limitation of wherein the collagen is obtained from a non-fish animal source is met by the ‘291 publication teaching mammalian or non-mammalian species that include rats, human and fish, preferable bovine tendon [0072].
Regarding claim 26, the limitation of wherein the conformable matrix has a thickness between about 5mm and about 10 mm is met by the ‘291 publication teaching height of 10 mm [0081].
That being said, however, it must be remembered that “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious”. KSR v. Teleflex, 127 S,Ct. 1727, 1740 (2007)(quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976)). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious”, the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR v. Teleflex, 127 S.Ct. 1727, 1741 (2007). The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742.
Consistent with this reasoning, it would have been obvious to have selected various combinations of disclosed ingredients (for example, a strip comprising collagen and bioactive glass comprising the claimed range of V2)3) from within the prior art disclosure of the ‘291 publication, to arrive at the instantly claimed article comprising a conformable matrix “yielding no more than one would have expected from such an arrangement”.
Response to Arguments:
Applicant’s claim amendments have been fully considered and are not deemed to be persuasive.
103: the ‘473 publication in view of the ‘131 publication and the ‘500 publication
Applicant argues the cited references od not teach the bioactive glass includes between 10 wt% and 75 wt% B2O3.
In response, the ‘131 publication teaches the bioactive glass is taught to comprise silicon dioxide, sodium oxide, calcium oxide and phosphorus oxide (claim 10), reading on claim 22. The preferred range of B2O3 is from 0 to about 10% by weight [0038]. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Applicant argues claims 20 and 24 are dependent from claim 1 and thus allowable for the same reasons.
In response, Applicant’s arguments regarding claim 1 are addressed as first presented.
Applicant argues claims 25 and 26 are newly added and patentable for the same reasons as claim 1.
In response, Applicant’s arguments regarding claim 1 are addressed as first presented.
Conclusion
No claims are allowed.
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/LYNDSEY M BECKHARDT/Examiner, Art Unit 1613
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