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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 10/31/2025 has been entered.
Status of the Claims
Claim 2 has been cancelled.
Claims 1and 3-17 are pending and currently under examination.
All rejections not reiterated have been withdrawn.
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.
Claims 8-11, and 13 are 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 8 recites the limitation "the average particle size" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 8 recites the phrase “preferably” in line 2. This language renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP2173.05(d).
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 8 recites the broad recitation less than 50 microns, and the claim also recites less than 1 micron which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 9 recites the limitation "the matrix phase polymer material” in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 9 recites the limitation "the reinforcing phase fibers” in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 9 recites the phrase “preferably” in lines 2 and 3. This language renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP2173.05(d).
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 9 recites the broad recitation 30 wt% to 90 wt%, and the claim also recites 30 wt% to 89 wt% which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 9 recites the broad recitation 10 wt% to 69 wt%, and the claim also recites 1 wt% to 30 wt% which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 10 recites the limitation "the matrix materials” in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitation "the flexural strength” in lines 6 and 10. There is insufficient antecedent basis for this limitation in the claim.
Claim 11 recites the limitation "the materials” in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 11 recites the limitation "the reinforcing phase” in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 11 recites the limitation "the resorbable matrix phase” in lines 3 and 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 11 recites the limitation "the melted resorbable matrix phase” in lines 6, 7, 9, 10 and 12. There is insufficient antecedent basis for this limitation in the claim.
Claim 11 recites the limitation "the material” in line 17. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 3 and 14-17 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
In this case, claim 3 fails to further limit the subject matter of the claim upon which they depend because claim 1 from which it depends limits the reinforcing fibers to polylactide (PLA), poly(vinyl alcohol)(PVA) or polyglycolide (PGA), whiles claim 3 has a broader scope of the reinforcing fibers.
In this case, claims14-17 fails to further limit the subject matter of the claim upon which they depend because claim 1 from which it depends limits the reinforcing fibers to polylactide (PLA), poly(vinyl alcohol)(PVA) or polyglycolide (PGA), whiles claims 14-17 have a broader scope of the reinforcing fibers.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claims 1, 3-10 and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Tormala et al. (US20100121463A1, Published 05/13/2010; as cited in the IDS filed 05/13/2022).
Applicant’s Invention
The claims are drawn to a composition comprising: a) a resorbable matrix; b) one or more reinforcing fiber(s) impregnated into the resorbable matrix using LFRT process; wherein the resorbable matrix comprises a poly(s-caprolactone) (PCL),poly(dioxanone) (PDO), isomers, copolymers or blends thereof; wherein the reinforcing fiber(s) comprises a polylactide (PLA), poly(vinyl alcohol) (PVA) or polyglycolide (PGA); and wherein the resorbable matrix and the reinforcing fibers(s) optionally contain additives.
Determination of the scope and the content of the prior art
(MPEP §2141.01)
Regarding claim 1, Tormala teaches bioabsorbable and bioactive composition material comprising a bioabsorbable polymeric matrix material (i.e., resorbable matrix) which is reinforced with bioabsorbable polymeric fibers (i.e., reinforcing fibers) and bioabsorbable ceramic fibers (i.e., additives)(abstract). The examiner notes that the instant claim 1 uses product by process language, “using LFRT process”. "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). See MPEP 2113 (I).
Tormala also teaches in example 1, the mixture of the matrix which is Poly-L/DL-lactide, a polymer fiber-reinforcement which is Poly-L/DL-lactide and glass fiber reinforcement (i.e., additive) (paragraphs [0080-0082]). Tormala further teaches bioabsorbable polymers suitable as polymeric fibers and for the bioabsorbable polymeric matrix in table 1, such as polylactides (PLA), polyglycolide (PGA), poly(ɛ-caprolactone), poly(dioxanone), and polyvinyl alcohol (PVA) (paragraph 0066]).
Regarding claims 3 and 14-15, Tormala teaches bioabsorbable polymers suitable as polymeric fibers and for the bioabsorbable polymeric matrix in table 1 such as poly(lactic acid), poly(glycolic acid), poly(lactide-co-glycolide), poly (lactide-co-caprolactone), poly(lactide-co-trimethylene carbonate), poly(glycolide -co-trimethylene carbonate) (i.e., resorbable materials) and polyvinyl alcohol (i.e., non-resorbable materials) (paragraph [0066]). Tormala further teaches there should be a sufficient amount bioactive glass fibers (i.e., non-resorbable material) (paragraph [0054]).
Regarding claims 4 and 5, Tormala teaches bioceramics (i.e., inorganic additives) in table 2 such as hydroxyapatite, calcium phosphates, and tricalcium phosphates (paragraph [0066]). Tormala further teaches additives such as antibiotics (paragraph [0041]).
Regarding claim 6, Tormala teaches the reinforcing fibers can be parallel or traverse to the longitudinal axis of the polymeric layer (i.e., aligned continuous) (paragraph [0061]). Tormala also teaches the reinforcing fibers can also be braided, knitted or woven together (paragraph [0042]).
Regarding claim 7, Tormala teaches thanks to the controlled manufacturing stages of combining of matrix and ceramic reinforcing fibers as well as polymeric reinforcing fibers, the amount of both reinforcing fiber types can be easily controlled. This is an advantage, because the ratio of the elements will affect the mechanical properties (i.e., tensile strength) of the device. Also, the amount of the ceramic reinforcing fibers will affect the bioactivity of the device (paragraph [0019]).
Regarding claim 8, Tormala teaches the diameters of the ceramic reinforcing fibers typically comprise of biodegradable, bioactive long fibers of bioactive glass with a diameter often between 1 micron and 20 micron (paragraph [0037]).
Regarding claim 9, Tormala teaches the amount of polymeric reinforcing fibers or ceramic reinforcing fibers in the composite is from 10 wt % to 90 wt %, preferably from 20wt % to 70 wt % (paragraph [0040]). Tormala also teaches in table 1, the use of PLA70 matrix content in the amount of 44-53 wt% (paragraph 0088]).
Regarding claim 10, Tormala teaches the amount of polymeric reinforcing fibers or ceramic reinforcing fibers in the composite is from 10 wt % to 90 wt %, preferably from 20wt % to 70 wt % (paragraph [0040]). Tormala also teaches the present invention relates to bioabsorbable materials and devices for musculoskeletal applications, such as e.g. bone fracture or osteotomy fixation, soft tissue (like tendon)-to-bone fixation, soft tissue-to-soft tissue fixation and guided bone regeneration applications, such as vertebral fusion (i.e., medical device articles) (paragraph [0034]).
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.02)
Tormala does not disclose a single embodiment or example where every limitation recited in the instant claims is taught.
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
The claims are considered prima facie obvious to one of ordinary skill in the art at the time of filing because Tormala teaches all of the claimed elements. It would have been prima facie obvious to one of ordinary skill at the time of filing to make a composition comprising: a) a resorbable matrix; b) one or more reinforcing fiber(s) impregnated into the resorbable matrix; and wherein the resorbable matrix and the reinforcing fibers(s) optionally contain additives because Tormala teaches and contemplates all the elements required to make the device for controlled delivery.
With regards to the limitation wherein the resorbable matrix comprises a poly(s-caprolactone) (PCL),poly(dioxanone) (PDO), isomers, copolymers or blends thereof, it would have been obvious to one of ordinary skill in the art to have the resorbable matrix comprise of poly(s-caprolactone) (PCL),poly(dioxanone) (PDO), isomers, copolymers or blends thereof in Tormala’s bioabsorbable and bioactive composite material. One would have understood in view of Tormala that a mixture of the matrix which is Poly-L/DL-lactide, a polymer fiber-reinforcement which is Poly-L/DL-lactide and glass fiber reinforcement (i.e., additive) is done in example 1 (paragraphs [0080-0082]). Tormala also teaches bioabsorbable polymers suitable as polymeric fibers and for the bioabsorbable polymeric matrix in table 1, such as polylactides (PLA), polyglycolide (PGA), poly(ɛ-caprolactone), poly(dioxanone), and polyvinyl alcohol (PVA) (paragraph 0066]), wherein the matrix component can be any bioabsorbable or bioerodible polymer, copolymer or polymer alloy (mixture of two or more polymers or copolymers) (paragraph [0034]). It would have been obvious to one of ordinary skill in the art to have the resorbable matrix comprise of poly(s-caprolactone) (PCL), poly(dioxanone) (PDO), isomers, copolymers or blends thereof in Tormala’s bioabsorbable and bioactive composite material because Tormala suggest the combination of the matrix which is Poly-L/DL-lactide, a polymer fiber-reinforcement which is Poly-L/DL-lactide and glass fiber reinforcement (i.e., additive) in example 1 (paragraphs [0080-0082]); that the bioabsorbable polymers suitable as the bioabsorbable polymeric matrix in table 1, such as poly(ɛ-caprolactone), poly(dioxanone) (paragraph 0066]), therefore, poly(ɛ-caprolactone) and poly(dioxanone) are suitable as a substitution as bioabsorbable polymers for the polymeric matrix. See MPEP 2144.06 (II). Tormala also teaches wherein the matrix component can be any bioabsorbable or bioerodible polymer, copolymer or polymer alloy (mixture of two or more polymers or copolymers), therefore, poly(ɛ-caprolactone) and poly(dioxanone) are suitable to be combined with Poly-L/DL-lactide taught as the matrix polymer in example 1. See MPEP 2144.06(I).
Claims 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Tormala et al. (US20100121463A1, Published 05/13/2010; as cited in the IDS filed 05/13/2022) in view of Dyksterhouse (US20030166764A1, Published 09/04/2003).
Applicant’s Invention
Tormala renders obvious all the limitations of claim 1. Applicant’s claim 11 further adds the limitation wherein a long fiber resorbable thermoplastic process of making the composition of claim 1, wherein the process comprises impregnating the materials in the reinforcing phase into the resorbable matrix phase by: a. melting the resorbable matrix phase using an extruder, reactor, or melt pump; b. routing the melted resorbable matrix phase into a die; c. routing the melted resorbable matrix phase inside the die to a flat strip area; d. feeding fiber bundles into the flat strip area where the bundles are incorporated into the melted resorbable matrix phase; e. pulling the fiber bundles and the melted resorbable matrix phase through the die over high-pressure zones with rollers; f. forcing the melted resorbable matrix phase into the fiber bundles by wetting the fiber bundles, thereby forming a pre-impregnated material coming out of the die; and g. collecting the pre-impregnated material that is formed into a flat strand or a circular strand; and h. optionally pelletizing the material for injection molding. Applicant’s claim 12 further adds the limitation wherein an injection moldable fiber reinforced material comprising the composition of claim 1, wherein the resorbable matrix and the reinforcing fibers comprises polymeric materials; wherein the polymeric materials are selected in such a way that the processing temperature of the matrix polymer is less than the glass transition temperature of the fibers plus 132°C. Applicant’s claim 13 further adds the limitation wherein i) the processing temperature of the matrix polymer has a minimum temperature that would yield a complex viscosity of 12 kPa*s or less as determined by rheology; and/or ii) the resorbable matrix and the reinforcing fiber(s) comprises polymeric materials; wherein the polymeric materials are selected in such a way that the difference between the melting points of the reinforcing phase polymer and the resorbable matrix phase polymer is not less than 50°C; and/or iii) the resorbable matrix phase polymer or the reinforcing phase polymer are amorphous, wherein the melting point temperature is replaced by the melt flow temperature of the polymer that corresponds to a melt flow index of 10 g/ 10min.
Determination of the scope and the content of the prior art
(MPEP §2141.01)
Regarding claim 11, Tormala teaches processing methods include for example prepregging methods such as melt impregnation (paragraph [0044]).
Regarding claims 12-13, Tormala teaches one advantageous method is injection molding, in which the polymer fiber and a ceramic fiber insert is located inside the mold and a polymer melt is injected into the mold to fill the pores inside the fiber insert and the possible open space around the insert. Thereafter, the mold is cooled down so that the polymer melt (matrix) becomes solid and the composite sample can be removed from the mold (paragraph [0076]).
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.02)
Tormala does not teach wherein a long fiber resorbable thermoplastic process of making the composition of claim 1, wherein the process comprises impregnating the materials in the reinforcing phase into the resorbable matrix phase by: a. melting the resorbable matrix phase using common methods such as extruder, reactor, or melt pump; b. routing the melted resorbable matrix phase into a die; c. routing the melted resorbable matrix phase inside the die to a flat strip area; d. feeding fiber bundles into the flat strip area where the bundles are incorporated into the melted resorbable matrix phase; e. pulling the fiber bundles and the melted resorbable matrix phase through the die over high-pressure zones indie the die, such as narrow sections or rollers; f. forcing the melted resorbable matrix phase into the fiber bundles by wetting the fiber bundles, thereby forming a pre-impregnated material coming out of the die; and g. collecting the pre-impregnated material that is formed into a flat strand or a circular strand; and h. optionally pelletizing the material for injection molding. Tormala also does not teach wherein the polymeric materials are being selected in such a way that the processing temperature of the matrix polymer is less than the glass transition temperature of the fibers plus 132°C; and wherein i) the processing temperature of the matrix polymer has a minimum temperature that would yield a complex viscosity of 12 kPa*s or less as determined by rheology; and/or ii) the resorbable matrix and the reinforcing fiber(s) comprises polymeric materials; wherein the polymeric materials are being selected in such a way that the difference between the melting points of the reinforcing phase polymer and the resorbable matrix phase polymer is not less than 50°C; and/or iii) the resorbable matrix phase polymer or the reinforcing phase polymer are amorphous, wherein the melting point temperature is replaced by the melt flow temperature of the polymer that corresponds to a melt flow index of 10 g/ 10min. However, these deficiencies are cured by Dyksterhouse.
Dyksterhouse teaches a new process for preparing prepregs, novel prepregs, and articles of reinforced materials (paragraph [0007]). Dyksterhouse also teaches in example 5, melting the resin (i.e., resorbable matrix) using an extruder and then forcing the molten resin into an impregnation die which has three heating zones(paragraph [0047]), then a resin delivery channel (paragraph [0049). Dyksterhouse further teaches a tow of S2 glass (i.e., fiber bundles) was threaded through the impregnation die, entering through an inlet die and exiting through a sizing die (paragraph [0048]), wherein hot fiber was pulled through the impregnation die and the resulting impregnated tow had a resin content and a glass fiber content (paragraph [0050]). Dyksterhouse also teaches the container has an inlet through which the fibrous reinforcing material enters the container and an outlet through which the fibrous reinforcing material exits the container, wherein the container may be an impregnation die. The temperature to which the fibrous reinforcing material is heated is thus sufficient to cause the impregnating resin to fully or substantially fully wet out the fibrous reinforcing material. The container may further comprise an opening through which pressure is applied to the molten resin (paragraph [0022]). Dyksterhouse continues to teach the prepreg is cut or trimmed to a desired shape (i.e., flat strand or circular strand)(paragraph [0031]). Dyksterhouse further teaches the fiber bundle, or other reinforcing material is heated to a selected temperature above the melting point, softening point, or glass transition temperature (Tg) of the impregnating resin matrix composition. The temperature to which the fibrous reinforcing material is heated is thus sufficient to cause the impregnating resin to fully or substantially fully wet out the fibrous reinforcing material. The reinforcement is heated to at least about 25° F., preferably to at least about 50° F., still more preferably to at least about 75° F., and even more preferably to at least about 100° F. above the melting point, softening point, or Tg of the resin matrix composition; and up to about 500° F., preferably up to about 400° F., particularly preferably up to about 350° F., and even more preferably up to about 300° F. above the melting point, softening point, or Tg of the resin matrix composition (paragraph [0018]).
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been prima facie obvious to one of ordinary skill in the art at the time of filing to have a thermoplastic impregnating process in Tormala’s prepregging methods such as melt impregnation. Tormala teaches bioabsorbable and bioactive composition material comprising a bioabsorbable polymeric matrix material (i.e., resorbable matrix) which is reinforced with bioabsorbable polymeric fibers (i.e., reinforcing fibers) and bioabsorbable ceramic fibers (i.e., additives)(abstract), wherein processing methods include for example prepregging methods such as melt impregnation (paragraph [0044]). One would have understood in view of Dyksterhouse that the process of the invention includes heating the fiber or other reinforcing material; bringing the heated reinforcing material into contact with the matrix resin composition under an applied shear to form a prepreg; and, optionally, further forming the prepreg into a desired shape (paragraph [0012]), wherein the container has an inlet through which the fibrous reinforcing material enters the container and an outlet through which the fibrous reinforcing material exits the container, wherein the container may be an impregnation die. The temperature to which the fibrous reinforcing material is heated is thus sufficient to cause the impregnating resin to fully or substantially fully wet out the fibrous reinforcing material (paragraph [0022]). It would have been obvious to one of ordinary skill in the art to a thermoplastic impregnating process in Tormala’s prepregging methods such as melt impregnation because Tormala teaches processing methods include for example prepregging methods such as melt impregnation (paragraph [0044]) and Dyksterhouse teaches the process of the invention includes heating the fiber or other reinforcing material; bringing the heated reinforcing material into contact with the matrix resin composition under an applied shear to form a prepreg (paragraph [0012]), wherein the container has an inlet through which the fibrous reinforcing material enters the container and an outlet through which the fibrous reinforcing material exits the container, wherein the container may be an impregnation die.
With regards to claims 12 and 13, wherein the polymeric materials are being selected in such a way that the processing temperature of the matrix polymer is less than the glass transition temperature of the fibers plus 132°C and wherein the polymeric materials are being selected in such a way that the difference between the melting points of the reinforcing phase polymer and the resorbable matrix phase polymer is not less than 50°C, it would have been prima facie obvious to one of ordinary skill in the art to have such polymeric materials selected in Tormala’s bioabsorbable and bioactive composition material comprising a bioabsorbable polymeric matrix material (i.e., resorbable matrix) which is reinforced with bioabsorbable polymeric fibers (i.e., reinforcing fibers). One would have understood in view of Dyksterhouse that the fiber bundle, or other reinforcing material is heated to a selected temperature above the melting point, softening point, or glass transition temperature (Tg) of the impregnating resin matrix composition. The temperature to which the fibrous reinforcing material is heated is thus sufficient to cause the impregnating resin to fully or substantially fully wet out the fibrous reinforcing material. The reinforcement is heated to at least about 25° F., preferably to at least about 50° F., still more preferably to at least about 75° F., and even more preferably to at least about 100° F. above the melting point, softening point, or Tg of the resin matrix composition; and up to about 500° F., preferably up to about 400° F., particularly preferably up to about 350° F., and even more preferably up to about 300° F. above the melting point, softening point, or Tg of the resin matrix composition (paragraph [0018]). It would have been obvious to one of ordinary skill in the art to such polymeric materials selected in Tormala’s bioabsorbable and bioactive composition material comprising a bioabsorbable polymeric matrix material (i.e., resorbable matrix) which is reinforced with bioabsorbable polymeric fibers (i.e., reinforcing fibers) because Dyksterhouse teaches that the fiber bundle or reinforcing material (i.e., polymeric materials) is heated to a selected temperature above the melting point, or glass transition temperature (Tg) of the impregnating resin matrix composition. Therefore, the processing temperature of the matrix polymer will be less than the glass transition of the fibers plus 132°C and the difference between the melting points of the reinforcing phase polymer and the matrix phase polymer is not less than 50°C because Dyksterhouse teaches the reinforcement is heated to at least about 25° F., preferably to at least about 50° F., still more preferably to at least about 75° F., and even more preferably to at least about 100° F. above the melting point, softening point, or Tg of the resin matrix composition; and up to about 500° F., preferably up to about 400° F., particularly preferably up to about 350° F., and even more preferably up to about 300° F. above the melting point, softening point, or Tg of the resin matrix composition (paragraph [0018]).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Tormala et al. (US20100121463A1, Published 05/13/2010; as cited in the IDS filed 05/13/2022) in view of King et al. (US20040002770A1, Published 01/01/2004).
Applicant’s Invention
Tormala renders obvious all the limitations of claim 1. Applicant’s claim 16 further adds the limitation wherein the natural materials comprise silk, collagen, keratin, chitin, chitosan, or elastin.
Determination of the scope and the content of the prior art
(MPEP §2141.01)
Regarding claim 1, Tormala teaches bioabsorbable and bioactive composition material comprising a bioabsorbable polymeric matrix material (i.e., resorbable matrix) which is reinforced with bioabsorbable polymeric fibers (i.e., reinforcing fibers) and bioabsorbable ceramic fibers (i.e., additives)(abstract). Tormala further teaches the polymers can be natural polymers (such as starch) (paragraph [0034]), wherein the bioabsorbable polymers are suitable as polymeric fibers and for the bioabsorbable polymeric matrix in table 1 (paragraph [0066]).
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.02)
Tormala does not teach wherein the natural materials comprise silk, collage, keratin, chitin, chitosan, or elastin. However, this deficiency is cured by King et al.
In the analogous art of polymer-bioceramic composites, King teaches suitable bioerodable polymers of natural origin for use as a matrix in the composite include, but are not limited to, collagen, chitin, chitosan, starch, and silk (paragraph [0032]).
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been prima facie obvious to one of ordinary skill in the art at the time of filing to have a natural material as the reinforcing fiber in Tormala’s bioabsorbable and bioactive composition material comprising a bioabsorbable polymeric matrix material (i.e., resorbable matrix) which is reinforced with bioabsorbable polymeric fibers (i.e., reinforcing fibers). Tormala teaches the polymers can be natural polymers (such as starch) (paragraph [0034]), wherein the bioabsorbable polymers are suitable as polymeric fibers and for the bioabsorbable polymeric matrix in table 1 (paragraph [0066]). One would have understood in view of King that suitable polymers of natural origins can be collagen, chitin, chitosan, starch and silk (paragraph [0032]). It would have been obvious to one of ordinary skill in the art to have natural materials as the reinforcing fiber in Tormala’s bioabsorbable and bioactive composition material comprising a bioabsorbable polymeric matrix material (i.e., resorbable matrix) which is reinforced with bioabsorbable polymeric fibers (i.e., reinforcing fibers) because Tormala teaches that natural fibers can be used such as starch and King teaches suitable polymers of natural origins can be collagen, chitin, chitosan, starch and silk (paragraph [0032]). Therefore, natural polymers such as collagen, chitin, chitosan, silk, starch are suitable as reinforcing fibers. See MPEP 2144.07.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Tormala et al. (US20100121463A1, Published 05/13/2010; as cited in the IDS filed 05/13/2022) in view of Dyksterhouse (US20030166764A1, Published 09/04/2003) in further view of Nies et al. (US20150066144A1, Published 03/05/2015).
Applicant’s Invention
Tormala renders obvious all the limitations of claim 1. Applicant’s claim 17 further adds the limitation wherein the metallic materials comprise magnesium, iron, zin, or alloys thereof.
Determination of the scope and the content of the prior art
(MPEP §2141.01)
Regarding claim 1, Dyksterhouse teaches all types of fiber reinforcements or other reinforcing materials commonly used are polymeric fibers and metal fibers (paragraph [0014]).
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.02)
Tormala does not teach wherein the wherein the metallic materials comprise magnesium, iron, zin, or alloys thereof. However, this deficiency is cured by Nies et al.
In the analogous art of fiber composite materials, Nies teaches resorbable mineral bone cement as the matrix material, to which reinforcing, long metal fibers and/or endless metallic fibers are added in the form of at least one fiber structure (paragraph [0011]). Nies also teaches the metallic fibers are comprised of a resorbable metal (also called bio-corrodible here), preferably selected from pure iron, zinc, magnesium, base iron alloys, zinc alloys or magnesium alloys (paragraph [0049]).
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been prima facie obvious to one of ordinary skill in the art at the time of filing to have metallic materials in Tormala’s bioabsorbable and bioactive composition. Dyksterhouse teaches that all types of fiber reinforcements or other reinforcing materials commonly used are polymeric fibers and metal fibers. One would have understood in view of Nies that metallic fibers can be selected from pure iron, zinc, magnesium, base iron alloys, zinc alloys, magnesium alloys (paragraph [0049]). It would have been obvious to one of ordinary skill in the art to have metallic materials as the reinforcing fiber in Tormala’s bioabsorbable and bioactive composition material because Dyskerhouse teaches all types of fiber reinforcements or other reinforcing materials commonly used are polymeric fibers and metal fibers, and Nies teaches that metallic fibers can be selected from pure iron, zinc, magnesium, base iron alloys, zinc alloys, magnesium alloys (paragraph [0049]). Therefore, metallic materials such as pure iron, zinc, magnesium, base iron alloys, zinc alloys, magnesium alloy are suitable as reinforcing fibers. See MPEP 2144.07.
Response to Arguments
Applicant's arguments filed 10/31/2025 have been fully considered but they are not persuasive.
On page 8 of Applicants remarks, Applicants argue that the same arguments presented for the 102 rejection also applies to the 103 rejection. On pages 7 of Applicants 102 rejection remarks, Applicants argue that the inventiveness of our process lies in selection of matrix and fiber material with a low processing temperature that allows fibers to maintain their strength during the process, therefore, the specific combination of resorbable matrix and reinforcing fibers in current claim 1 would achieve this result, and Tormala does not attempt to solve this problem, or suggest or teach this specific resorbable matrix/reinforcing fiber(s) combination.
These arguments are not persuasive. The examiner points out it would have been obvious to one of ordinary skill in the art to have the resorbable matrix comprise of poly(s-caprolactone) (PCL), poly(dioxanone) (PDO), isomers, copolymers or blends thereof in Tormala’s bioabsorbable and bioactive composite material because Tormala suggest the combination of the matrix which is Poly-L/DL-lactide, a polymer fiber-reinforcement which is Poly-L/DL-lactide and glass fiber reinforcement (i.e., additive) in example 1 (paragraphs [0080-0082]); that the bioabsorbable polymers suitable as the bioabsorbable polymeric matrix in table 1, such as poly(ɛ-caprolactone), poly(dioxanone) (paragraph 0066]), therefore, poly(ɛ-caprolactone) and poly(dioxanone) are suitable as a substitution as bioabsorbable polymers for the polymeric matrix. See MPEP 2144.06 (II). Tormala also teaches wherein the matrix component can be any bioabsorbable or bioerodible polymer, copolymer or polymer alloy (mixture of two or more polymers or copolymers), therefore, poly(ɛ-caprolactone) and poly(dioxanone) are suitable to be combined with Poly-L/DL-lactide taught as the matrix polymer in example 1. See MPEP 2144.06(I).
In response to applicant's argument that Tormala does not attempt to solve the problem or suggest or teach the specific resorbable matrix/reinforcing fiber(s) combination that is solved by Applicants wherein the fibers are incorporated into a resorbable polymer matrix through an impregnated process, which requires a polymer with low viscosity and with a melting temperature lower than that of the fibers, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Conclusion
No claims are allowed.
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AFUA BAMFOAA BOATENG Examiner, Art Unit 1617
/ALI SOROUSH/ Supervisory Patent Examiner, Art Unit 1614