Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined pursuant to the first inventor to file provisions of the AIA .
DETAILED ACTION
Status of the Claims
The Examiner acknowledges receipt of Applicant’ Response, filed 26 August 2025. No claims were amended therein. Upon finalization and entry of the Restriction/Election Requirement (see below), claims 1 – 42 will be available for substantive examination.
Response to Restriction Requirement
Applicant's election with traverse of the claims of Group I, claims 26 – 42, in the Response 26 August 2025, is acknowledged. The traversal is on the grounds that “Zhang [CN ‘341] does not teach or suggest the specific copolymer system required by the claims,” and that “the identified common technical [feature] does make a ‘contribution’ over the prior art, and therefore constitutes a ‘special technical feature’ within the meaning of PCT Rule 13.2.” More specifically, Applicant argue that “Zhang merely discloses broad lists of possible biodegradable polymers, including polyurethane, polyhydroxy fatty acid esters, and polylactic acid, with no restriction on monomer type, terminal groups, molecular ratios, or any specific diisocyanate subclass.” The Examiner respectfully disagrees. Despite the alleged “breadth” that Applicant decry, the reference specifically discloses polymeric material comprising polyurethanes copolymers comprising poly(ɛ-caprolactone)diol and L-lysine diisocyanate (see claim 4; cf. “prepolymer (A)”), PLGA with the ratio of lactic acid:glycolic acid of 1:1 – 1:10, with average molecular weights of 1,000 to 1,000,000 Da (see ¶[0016]; cf. “prepolymer (B)”), as well as type I or II human collagen (see ¶[0010]), and growth factors (see ¶[0011]), the polymeric material including stem cells (see ¶[0025]). Consequently, it is the Examiner’s position that the reference discloses the material as claimed with sufficient specificity to establish that Applicant’ invention fails to make a contribution over the prior art. The Restriction Requirement is, therefore, maintained and made FINAL.
Claims 43-45 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 8/26/2025.
Consequently, claims 26 – 42 are available for substantive examination.
Information Disclosure Statement
The Examiner has considered the Information Disclosure Statement (IDS) filed 27 June 2025, which is now of record in the file.
Rejections Pursuant to 35 U.S.C. § 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.
Claims 32, 35, 39, and 40 are rejected pursuant to 35 U.S.C. § 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
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 32 recites the broad recitation, “the polymer matrix has a mean molecular weight greater than 100000 g/mole,” and the claim also recites “wherein the polymer matrix has a mean molecular weight . . . ranging from 250000 g/mole to 400000 g/mole,” which is the narrower statement of the range/limitation. The claim is 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 35 recites a limitation directed to “it further comprises one or more types of live cells.” The claim is indefinite because one of ordinary skill in the art would be uncertain as to what the “it” refers. Appropriate correction or cancelation is necessary.
Claims 39 and 40 recite limitations directed to “prevention or treatment of knee arthrosis, particularly of grade 3 or 4 arthrosis of the knee.” Use of the term, “particularly,” renders the claim indefinite because one of skill in the art would be uncertain as to whether the limitation directed to “grade 3 or 4 arthrosis of the knee” is a required or an optional limitation.
Appropriate correction or cancelation of the claims is necessary.
Priority
The Examiner acknowledges receipt of papers submitted pursuant to 35 U.S.C. §§ 119(a)-(d), which papers are now of record in the file.
Rejections Pursuant to 35 U.S.C. § 103
The following is a quotation of 35 U.S.C. § 103 that 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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 absent any evidence to the contrary. Applicant are advised of the obligation pursuant to 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 26 – 42 are rejected pursuant to 35 U.S.C. § 103, as being obvious over CN 106267341 to Zhang, W., published 4 January 2017, identified on the Information Disclosure Statement (IDS) filed 27 June 2022, cite no. 1 (FOR) (“CN ‘341”)1, in view of FR 1870742 A to Assor, M., claiming priority to 4 June 2018 (“Assor FR ‘742”)1.
The Invention As Claimed
Applicant claim a porous biocomposite material comprising a polymer matrix having
pores defined by several surfaces, and collagen which at least partially covers the surfaces of the pores and the outer surfaces of the polymer matrix, wherein the polymer matrix comprises a copolymer which is a reaction product of a mixture comprising a prepolymer (A) which is a poly(ɛ-caprolactone) diol; a prepolymer (B) which is a poly(lactide-co-glycolide) terminated by a hydroxyl group at both ends of the molecules thereof and which has a molar ratio of lactide to glycolide ranging from 75:25 to 50:50; and a diisocyanate (C) which is a C1 to C4 alkyl ester of lysine diisocyanate; and, optionally a catalyst, the molar ratio between prepolymer (A) and prepolymer (B) in the mixture being from 10:90 to 90:10; and the molar quantity of diisocyanate (C) in the mixture being approximately once the total quantity of prepolymer (A) and prepolymer (B); and the ratio, by weight, of collagen to polymer matrix, is from 20:80 to 40:60, wherein the material is bioresorbable, biocompatible, and biodegradable, wherein prepolymer (A) and prepolymer (B) are biocompatible and biodegradable, and each have a molecular weight ranging from 600 g/mol to 15000 g/mol, or greater than 15000 g/mol, wherein prepolymer (B) has a molar ratio of lactide to glycolide of 50:50, wherein the pore size of the polymer matrix is between 25 microns and 500 microns, wherein the polymer matrix has a porosity from 40% to 95% by volume, wherein the polymer matrix has a mean molecular weight greater than 100000 g/mole, and a mean molecular weight ranging from 250000 g/mole to 400000 g/mole, wherein the collagen is a human recombinant collagen, wherein the collagen is a type I or II collagen, or a combination thereof, wherein the material further comprises one or more types of live cells, wherein the live cells are selected from the group consisting of chondroblasts, chondrocytes, stem cells, mesenchymal stem cells, adipose stem cells, where said stem cells are not human embryonic stem cells, wherein the material further comprises at least one bioactive agent, wherein the porous polymer matrix is presented in the form of a molded body that has the shape of a lateral or medial meniscus of the knee, wherein the material is in a form suitable for use as an implant for the repair of a lateral or medial meniscus lesion of the knee, cartilage, and/or prevention or treatment of a joint lesion of the knee, and/or prevention or treatment of knee arthrosis, particularly of grade 3 or 4 arthrosis of the knee.
Applicant also claim an implant for the repair of a knee meniscus lesion, and/or treatment of a knee joint cartilage lesion, and/or prevention or treatment of knee arthrosis, particularly of grade 3 or 4 arthrosis of the knee; and/or regeneration of knee joint cartilage, wherein the implant comprises the biocomposite material of claim 26, wherein the implant is in the form of a single C shape suitable for use for both the lateral meniscus and the medial meniscus, and the implant is progressively resorbed after implantation in a patient in 6 to 18 months after implantation.
The Teachings of the Cited Art
Zhang CN ‘341 discloses a biodegradable bioresorbable material that is composed of biocompatible biodegradable polyurethane, the polyurethane comprising a poly(lactic acid-glycolic acid) copolymer, wherein proportions of components are adjusted according to the requirements of the implantation site of different components in the body, the material performance, degradation rate, and pH value, so as to better serve the patient (see Abstract), wherein the polyurethane (PU) materials comprise poly(ɛ-caprolactone)diol (PCL) as a soft segment, L-lysine diisocyanate (LDI) and chain-protecting 1,4-butanediol (BDO) as hard segments, with a poly(glycolide-lactide), having a viscosity average molecular weight of 1000 – 1000000 g/mol (see claim 4), wherein the materials are prepared by electrospinning and the spinning process parameters are adjusted, and the shape of the receiving device is changed, to obtain static spinning composite nanomaterials of different shapes (see claim 7), wherein the biomaterial further comprises mitogens and stem cells, wherein the mitogens are selected from nerve growth factor, mitogen-derived nerve growth factor, mitogen-activated protein kinase, ciliary nerve mitogen-activated protein kinase, interleukin-1-6 cell growth factor, leukocyte inhibitory factor, pancreatic growth factor, pancreatic mitogen-activated protein kinase, epidermal growth factor, pancreatic mitogen-activated protein kinase, platelet-derived growth factor, and cytotoxic growth factor B, wherein the stem cells comprise totipotent stem cells, pluripotent stem cells, and hematopoietic stem cells, specifically including hematopoietic stem cells, bone marrow syngeneic stem cells, neural stem cells, muscle stem cells, osteoblastic stem cells, endodermal stem cells, retinal stem cells, pancreatic stem cells, or more (see claim 8), wherein the biodegradable materials comprise PLGA with a ratio of LA:GA of from 1:1 - 10:1 (see ¶[0003]), wherein the materials comprise human type I and/or II collagen (see ¶[0010]), wherein
growth factors can be directly combined with the scaffold or combined with the scaffold after the scaffold is constructed, or by simultaneously transplanting cells into the materials that can secrete growth factors on the scaffolds (see ¶[0011]), wherein, by using biodegradable polyurethane as a substrate, the design provides space for the adhesion and ingrowth of repair cells, induces and promotes the endogenous repair of the tendon, ensures good mechanical properties, provides the mechanical strength required for tendon sheath suture, and facilitates manual operation, at the same time, facilitating entry of the synovial fluid components, stabilizing the tendon internal environment, preventing the invasion of surrounding tissues, and preventing the formation of repair scars (see ¶[0013]), wherein the biodegradable polyurethane material is made from one or two of polylactic acid polyurethane, poly(caprolactone) and two kinds of biodegradable polyurethane derivatives (see ¶[0016]), wherein the polyurethane compositions comprise molecular formulas A and B, with a weight percentage range of A:B from 0.01 - 1:1 - 0.1 (see ¶[0017]), wherein the biodegradable materials are synthesized by using PLGA of a specific molecular weight in the range of 200 – 2000 g/mole, and different diols to synthesize a lactic acid-glycolic acid copolyol, and the product is reacted with different diisocyanates, using octanoic acid as a catalyst (see ¶[0018]), wherein the viscosity average molecular weight of the biodegradable polymer material is from 500 to 1000000 g/mole (see ¶[0018]), and wherein, by adopting a static spinning process, the material surface/interface composition and structure design have a responsive adsorption/adhesion effect on specific proteins and cells, and the structure design of the tissue growth environment is suitable for the formation of specific tissues and capable of regulating cell gene expression and differentiation pathways, and the material can be made into different shapes (see ¶[0028]). The reference does not expressly disclose that the porosity of the polymer matrix is from 40 to 95% (vol) (claim 31), or that the collagen is human recombinant collagen (claim 33). The teachings of Assor FR ‘742 remedy those deficiencies.
Assor FR ‘742 discloses meniscal implant composites of polyurethane and collagen that are biodegradable, wherein the collagen is a non-animal, plant-based, recombinant human type I and/or type II collagen (see p. 1, 1st para.), wherein the high molecular weight polyurethane is commercially available from Orteq, Inc. as ACTIFIT® (see WO 2015/134028 A1, published 11 September 2015) (see p. 2, 3rd para.), wherein the composites are used to prepare C-shaped medical implants for repair of menisci (see p. 2, 4th para.), wherein the implants are in the form of a foam comprising high molecular weight polyurethane and layers of recombinant human collagen obtained from tobacco plants, available as COLLPLANTTM (see p. 2, 6th para.), wherein the composite polyurethane/collagen implants are manufactured using a 3D printer (see p. 2, 8th para.), wherein the polyurethane is prepared by a process comprising reacting a C1 – C10 alkylol, such as 1,4-butanediol, with ɛ-caprolactone to form a macrodiol, treating the macrodiol with a diisocyanate to obtain a macrodiisocyanate, reacting the macrodiisocyanate with a chain extender, such as 1,4-butanediol, wherein the molar ratio between the macrodiisocyanate and the diol is 1.00:1.01 – 1.00:1.03 (see p. 2, 10th para.), wherein the polyurethane polymer has an average molecular weight of about 140 kg/mol to about 240 kg/mol (see p. 3, 7th para.), wherein the macrodiol has terminal hydroxy groups a number average molecular mass of approximately 600 to approximately 3000 g/mol (see p. 3, last para.), wherein a preferred diisocyanate for use in biomedical applications is an aliphatic diisocyanate, such as 1,4-butanediol (see p. 4, 5th para.), wherein the implants/scaffolds are porous in order to allow tissue ingrowth, an interconnected porosity is imparted by particulate leaching (see p. 5, 5th para.; see also, p. 7, 4th para.), wherein the diameters of the interconnected pores is 30 µm (see p. 5, 6th para.), wherein the porosity obtained is 70 or 80% (see p. 7, 2nd para.), wherein the recombinant human collagen is obtained from seedlings of tobacco plants that have been transformed with five human genes essential for the production of collagen, and the collagen so obtained is virgin human collagen without prions or germs, is not an allergen, and does not elicit an immunological response (see p. 8, 10th para.).
Application of the Cited Art to the Claims
It would have been prima facie obvious before the filing date of the claimed invention to prepare a biodegradable, bioresorbable material that is composed of biocompatible biodegradable polyurethane, the polyurethane comprising a poly(lactic acid-glycolic acid) copolymer, wherein proportions of components are adjusted according to the requirements of the implantation site of different components in the body, the material performance, degradation rate, and pH value, so as to better serve the patient, wherein the polyurethane (PU) materials comprise poly(ɛ-caprolactone)diol (PCL) as a soft segment, L-lysine diisocyanate (LDI) and chain-protecting 1,4-butanediol (BDO) as hard segments, with a poly(glycolide-lactide), having a viscosity average molecular weight of 1000 – 1000000 g/mol, wherein the materials are prepared by electrospinning and the spinning process parameters are adjusted, and the shape of the receiving device is changed, to obtain static spinning composite nanomaterials of different shapes, wherein the biomaterial further comprises mitogens and stem cells, wherein the mitogens are selected from nerve growth factor, mitogen-derived nerve growth factor, mitogen-activated protein kinase, ciliary nerve mitogen-activated protein kinase, interleukin-1-6 cell growth factor, leukocyte inhibitory factor, pancreatic growth factor, pancreatic mitogen-activated protein kinase, epidermal growth factor, pancreatic mitogen-activated protein kinase, platelet-derived growth factor, and cytotoxic growth factor B, wherein the stem cells comprise totipotent stem cells, pluripotent stem cells, and hematopoietic stem cells, specifically including hematopoietic stem cells, bone marrow syngeneic stem cells, neural stem cells, muscle stem cells, osteoblastic stem cells, endodermal stem cells, retinal stem cells, pancreatic stem cells, or more, wherein the biodegradable materials comprise PLGA with a ratio of LA:GA of from 1:1 - 10:1, wherein the materials comprise human type I and/or II collagen (see ¶[0010]), wherein the polyurethane compositions comprise molecular formulas A and B, with a weight percentage range of A:B from 0.01 - 1:1 - 0.1, wherein the biodegradable materials are synthesized by using PLGA of a specific molecular weight in the range of 200 – 2000 g/mole, and different diols to synthesize a lactic acid-glycolic acid copolyol, and the product is reacted with different diisocyanates, optionally using octanoic acid as a catalyst, wherein the viscosity average molecular weight of the biodegradable polymer material is from 500 to 1000000 g/mole, and wherein, by adopting a static spinning process, the material surface/interface composition and structure design have a responsive adsorption/adhesion effect on specific proteins and cells, and the structure design of the tissue growth environment is suitable for the formation of specific tissues and capable of regulating cell gene expression and differentiation pathways, and the material can be made into different shapes, as taught by Zhang CN ‘341, wherein the high molecular weight polyurethane is commercially available from Orteq, Inc. as ACTIFIT® (see WO 2015/134028 A1, published 11 September 2015), wherein the composites are used to prepare C-shaped medical implants for repair of menisci, wherein the implants are in the form of a foam comprising high molecular weight polyurethane and layers of recombinant human collagen obtained from tobacco plants, available as COLLPLANTTM, wherein the composite polyurethane/collagen implants are manufactured using a 3D printer, wherein the polyurethane polymer has an average molecular weight of about 140 kg/mol to about 240 kg/mol, wherein the macrodiol has terminal hydroxy groups and a number average molecular mass of approximately 600 to approximately 3000 g/mol, wherein the implants/scaffolds are porous in order to allow tissue ingrowth, and interconnected porosity is imparted by particulate leaching, wherein the porosity obtained is 70 or 80%, wherein the recombinant human collagen is obtained from seedlings of tobacco plants that have been transformed with five human genes essential for the production of collagen, as taught by Assor FR ‘726. One of ordinary skill in the art would be motivated to do so, with a reasonable expectation of success in so doing, by the express teachings of Assor FR ‘726 to the effect that a recombinant human collagen is virgin human collagen without prions or germs, is not an allergen, so it does not elicit an immunological response, and that the interconnected porosity of the implant material allows for tissue ingrowth.
With respect to those claims reciting quantitative ranges for properties of the components or of the composite implants, the Examiner notes that the cited art does not discloses values or ranges of values that are exactly congruent with the claimed ranges. However, it is the Examiner’s position that the cited art teaches values, or ranges of values, that are encompassed by the claimed ranges, or that significantly overlap with the claimed ranges and, as such, would render the claimed invention obvious. See MPEP § 2144.05. “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).”
More specifically with respect to claim 26, which claim recites a limitation directed to a range of mass ratios between the polyurethane and collagen components of the implants, the Examiner notes that the cited references do not specifically disclose ratios that would read on the limitation at issue. However, the Examiner further notes that the references discloses that the structures and compositions of the implants can be adjusted to take into consideration the ultimate application of the implants. Furthermore, the references disclose that the implants may be prepared by 3D printing. Given the almost unlimited structural and compositional flexibility that 3D printing provides, and that compositions can be adjusted to fit desired applications, it is the Examiner’s position that preparation of two-component composite implants with proportions between the components reading on the claimed range amounts to nothing more than an optimization of a result-effective variable, the exercise of which is well within the expertise of one of ordinary skill in the appropriate art. Consequently, in the absence of evidence as to the criticality of such parameter, this limitation cannot support patentability. See MPEP § 2144.05 II. A.
With respect to claims 38 – 41, which claims recite limitations directed to uses of the claimed implants, it is the Examiner’s position that these recitations are nothing more than statements of intended use. Claim 26 is directed to a composition of matter. Thus, its subject matter must be distinguished from the prior art by its structure or composition. Cf. Hewlett- Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1468 (Fed. Cir. 1990) (holding that “apparatus claims cover what a device is, not what a device does.’’). Statements of intended use or function normally are not given patentable weight because they are not structurally limiting. Cf Cochlear Bone Anchored Sols. AB v. Oticon Med. AB, 958 F.3d 1348, 1354-55 (Fed. Cir. 2020).
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by claims 26 - 42 would have been obvious within the meaning of 35 USC § 103.
NO CLAIM IS ALLOWED.
CONCLUSION
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/DANIEL F COUGHLIN/
Examiner, Art Unit 1619
/DAVID J BLANCHARD/ Supervisory Patent Examiner, Art Unit 1619
1 All cites to Zhang CN ‘341 and Assor FR ‘742 are to machine-generated English translations of the documents.