DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after July 18, 2024, is being examined under the first inventor to file provisions of the AIA .
Status of the Application
Receipt is acknowledged of Applicants’ claimed invention filed on 07/18/2024 in the matter of Application N° 18/777,065. Said documents are entered on the record. The Examiner further acknowledges the following:
Thus, claims 1-21 represent all claims currently under consideration.
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 1 and 21 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.
With respect to claims 1 and 21, the phrase “for example” renders the scope of the claims indefinite because it introduces exemplary language without clearly defining whether the recited subject matter is required or merely illustrative. As a result, the metes and bounds of the claimed invention cannot be determined with reasonable certainty.
Claim 6 is rejected under 35 U.S.C. 112 (b) because the transitional phrase “consisting of” is inconsistent with the intended scope of the claim. As currently drafted, the claim is interpreted as being limited to polyester alone, thereby excluding any additional components. If additional ingredients are intended to be present, the transitional phrase should be amended to “further comprising” or other appropriate open-ended language.
Claim 8 is rejected under 35 U.S.C. 112(b) because the term “among” is indefinite in the context of the claimed range. The term does not clearly define the boundaries of the limitation. Replacing “among” with “between” would provide a definite range and clarify the scope of the claim.
Claims 9 and 13 are rejected under 35 U.S.C. 112 (b) because the simultaneous use of the transitional phrases “comprising” and “consisting of” creates ambiguity as to the intended scope of the claims. These transitional phrases have different legal meanings, making it unclear whether additional unrecited elements are permitted. For purposes of examination, the claims have been interpreted as though only the open-ended transitional phrase “comprising” were present.
Claim 19 is rejected under 35 U.S.C. 112(b) because the claim lacks clarity regarding the recited polymer. Specifically, polyester is itself a type of polymer, and is therefore unclear whether the claim requires the polymer to be a polyester or whether another polymer is intended. Accordingly, the scope of the limitation cannot be determined with reasonable certainty.
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.
Claim 21 is rejected under 35 U.S.C. 112(d) as being of improper dependent form. Claim 21 fails to further limit the subject matter of claim 1 because it merely recites intended uses of the composition rather than adding a further structural or substantive limitation to the composition itself. As drafted, claim 21 does not narrow the scope of the claim from which it depends.
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.
Claims 1-21 are rejected under 35 U.S.C. 103 as being unpatentable over Yang et al. (US8911720B2), in view of Lapuente Fernandez et al. (WO2020201404A1), and Slota et al. (Polymeric and composite carriers of protein and non-protein biomolecules for application in bone tissue engineering, 8 March, 2023), and Leblanc Latour et al. (WO2021119830A1), and Lupu-Haber et al. (Functionalized PLGA-doped zirconium oxide ceramics for bone tissue regeneration, 28 July, 2013), and Sakthiabirami et al., (Three-Dimensional Zirconia-Based Scaffolds for Load-Bearing Bone-Regeneration Applications: Prospects and Challenges 1 June, 2021), and Weng et al. (Review of zirconia-based biomimetic scaffolds for bone tissue engineering, 16 January, 2021), and Indira et al.,(A study on the development of scaffold fabrication using citric acid polyester-nanohydroxyapatite composite, 13 June, 2022), and Wang et al., Engineering multifunctional bioactive citrate-based biomaterials for tissue engineering, 24 April, 2022), and Cheng et al., (The effect of triethanolamine on the formation of sol-gel derived fluoroapatite/hydroxyapatite solid solution, 31 July, 2002, and Yang et al. (US8911720B2), and Djuric et al. (US20120053303A1), and Skoog et al., (Two-photon polymerization of 3-D zirconium oxide hybrid scaffolds for long-term stem cell growth, 17 April, 2014), and Sharif et al. (US5182408A).
Regarding claims 1, 7, 8, and 9, Yang et al. disclose citrate-based polyester biomaterials prepared by polycondensation of citric acid, corresponding to the claimed first element, with a diol having at least two hydroxyl groups, corresponding to the claimed second element. Yang et al. further discloses that the resulting poly (diol citrate) materials are suitable for biomedical and tissue-engineering applications (See Abstract, claim 1, and summary of the invention, paragraph 2).
Lapuente Fernandez et al. disclose a composition for obtaining a tissue regeneration or reconstruction material. Lapuente Fernandez et al. teach that the invention relates to regenerative medicine and tissue repair, wherein the composition is useful for the regeneration of mammalian tissues, including bone tissue (See Abstract and field of the invention, paragraph 1, figure 12, page 28-29, and paragraph 45). Accordingly, Lapuente Fernandez et al. teach a composition for obtaining a tissue regeneration or reconstruction material, including bone tissue, as recited in claim 1.
However, Lapuente Fernandez et al. do not expressly disclose that the composition is capable of transporting and/or releasing at least one pharmaceutical, nutraceutical, and/or cosmeceutical active ingredient.
Slota et al. disclose biologically safe carrier systems capable of transporting and releasing pharmaceutical, nutraceutical, and cosmetic active ingredients. Slota et al. teach that such carriers provide controlled delivery of bioactive molecules while maintaining biocompatibility (See Introduction and paragraph 1).
Leblanc et al. disclose scaffold biomaterial for bone tissue engineering and teach that scaffold materials provide an alternative to conventional bone grafts for regenerating bone defects. Leblanc et al. further teach that scaffold biomaterials may function as carriers for bioactive agents while promoting bone regeneration (See Abstract and Description, paragraphs 1 and 2).
Lupu-Haber et al. disclose composite scaffolds for bone tissue engineering comprising doped zirconium oxide conjugated with poly (lactic-co-glycolic acid) (PLGA) particles for the controlled delivery of growth factors. Specifically, Lupu-Haber et al. teach that PLGA microspheres are designed to release bone morphogenetic protein-2 (BMP-2), a growth factor that promotes bone formation, thereby teaching the incorporation of zirconium containing materials into compositions used for bone regeneration and controlled delivery of therapeutic agents (See Abstract).
Lupu-Haber et al. disclose controlled delivery of bone morphogenetic protein-2 (BMP-2). Specifically, zirconium scaffolds were washed, and 10 mg of uncapped PLGA microspheres were added to each scaffold using Sulfo-EDC, thereby teaching the incorporation of zirconium-containing scaffolds into a regenerative composition capable of delivering therapeutic agents (See 2.10 production of a scaffold, page 1058).
Sakthiabirami et al. disclose that zirconia exhibits desirable structural and mechanical properties for biomedical applications. Sakthiabirami et al. teach that zirconia undergoes a phase transformation from the monoclinic phase to the tetragonal phase, resulting in improved mechanical performance, making zirconia particularly suitable for load bearing bone tissue engineering applications (See Introduction, 1.1).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to incorporate the first element comprising at least two carboxyl (-COOH) groups and the second element comprising at least two hydroxyl (-OH) groups taught by Yang et al., and to incorporate the zirconium component taught by Weng et al. into the regenerative composition of the combined prior art. Yang et al. expressly teach preparing biodegradable citrate-based polyester biomaterials by reacting polycarboxylic acids, such as citric acid, with polyols, such as 1,8-octanediol, to produce biomaterials suitable for tissue engineering. Weng et al. teach that incorporating zirconium into regenerative biomaterials improves mechanical properties and enhances biological performance. Accordingly, one of ordinary skill in the art would have been motivated to combine the teachings of Yang et al. and Weng et al. to obtain a biodegradable zirconium-containing regenerative composition having improved mechanical strength and biological performance while maintaining suitability for tissue regeneration, with a reasonable expectation of success.
Weng et al. disclose that zirconia nanocomposites are widely used in bone tissue engineering because of their high mechanical strength, wear resistance, favorable low-temperature sintering properties, and ability to improve the biological activity of scaffold materials. Weng et al. further teach hydroxyapatite scaffolds synthesized with zirconia nanoparticles, wherein the incorporation of zirconia nanoparticles improved the biological behavior of the scaffold. Specifically, Weng et al. disclose a hydroxyapatite scaffold comprising 10 wt.% zirconia, thereby teaching a zirconium containing composition having a zirconium content within the claimed range of 5-20% by weight (See page 8312, paragraphs 3 and 4).
It would have been obvious to one of ordinary skill in the art to incorporate the zirconia content taught by Weng et al. into the regenerative scaffold composition of Yang et al., and Lapuente Fernandez et al., as modified by Slota et al., Leblanc et al., and Lupu-Haber et al., because Weng et al., demonstrate that incorporating 10 wt.% zirconia into bone scaffolds improves mechanical strength and biological performance. One of ordinary skill in the art would have reasonably expected that employing a zirconium content within the disclosed range would enhance the structural integrity and regenerative performance of the scaffold while maintaining its suitability for controlled delivery of bioactive agents.
Regarding claims 2, and 10, Indira et al. teach using citric acid as a monomer for preparing biodegradable polyester materials suitable for biomedical applications (See Abstract).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to select citric acid as the first element containing at least two carboxyl (COOH) groups in the composition of the combined prior art because Indira et al. teach that citric acid is a suitable multifunctional carboxylic acid monomer for preparing biocompatible and biodegradable polymeric materials. One of ordinary skill in the art would have been motivated to utilize citric acid in the regenerative composition to obtain the known benefits of citric acid-based polymers, including biocompatibility, biodegradability, and suitability for tissue engineering applications, with a reasonable expectation of success.
Regarding claims 3, 4, 5, and 11, Wang et al. disclose citrate-based biodegradable polymers and hydrogels for biomedical and tissue engineering applications. Specifically, Wang et al. teach the preparation of a biodegradable citrate-based elastic hydrogel by replacing 1,8-octanediol with polyethylene glycol (PEG) during cross linking with maleic acid, thereby evidencing the use of 1,8-octanediol as a suitable diol component in citrate-based biomaterials. Wang et al. further disclose that poly (glycerol sebacate) (PGS) is a commonly used biodegradable elastomer prepared by the polycondensation of glycerol and sebacic acid, thereby teaching glycerol as an additional second element suitable for biodegradable tissue engineering materials (See page 2, Introduction), and (page 20, 8.2.2).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to select 1,8-octanediol and/or glycerol as the second element of the composition because Wang et al. expressly teach that these compounds are conventional polyol components for preparing biodegradable citrate-based polymers and elastomeric biomaterials used in tissue engineering. One of ordinary skill in the art would have been motivated to incorporate these known polyols into the regenerative composition of the combined prior art to obtain predictable improvements in biocompatibility, elasticity, degradation behavior, and scaffold performance while maintaining suitability for tissue regeneration and controlled delivery applications. Furthermore, it would have been obvious to incorporate the zirconia content taught by Weng et al., as Weng et al. demonstrate that the addition of zirconia to bone scaffold compositions enhance mechanical strength and biological performance. Accordingly, one of ordinary skill in the art would have been motivated to combine the teachings of Wang et al. and Weng et al. with the closest prior art to obtain a regenerative composition exhibiting the known and predictable advantages associated with both the conventional polyol components and zirconia, with a reasonable expectation of success.
Regarding claim 6, Wang et al. disclose that polyester biomaterials are a class of synthetic biodegradable polymers processing controllable mechanical properties, favorable biodegradation characteristics, and excellent biocompatibility, making them particularly suitable for tissue engineering and regenerative medicine. Wang et al. further disclose unsaturated polyester-doped poly (octanediol citrate) (POC) elastomers, including those incorporating maleic acid, maleic anhydride, and itaconic acid, which have been widely investigated to improve the mechanical properties of citrate-based polyester biomaterials (See Introduction, and page 4, 2.2.2).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to employ a polyester composition in the regenerative material of the combined prior art because Wang et al. teach that polyester-based citrate polymers exhibit desirable mechanical strength, biodegradability, and biocompatibility for tissue engineering applications. Furthermore, Wang et al. teach that modifying citrate-based polyesters with unsaturated monomers, such as maleic acid, is a known approach to improve mechanical properties, thereby providing additional motivation to employ polyester materials in regenerative scaffold compositions with a reasonable expectation of success.
Regarding claims 12, 14, and 15, Cheng et al. disclose preparing solutions by dissolving components in ethanol to form 1 M solutions. Thus, Cheng et al. expressly teach the use of ethanol as a solvent for solubilizing a component used in the preparation of the composition (See Abstract, and page 768, Experimental procedure, paragraph 1).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to utilize ethanol as the solvent for solubilizing the first element of the regenerative composition because ethanol is a well-known, biocompatible solvent commonly employed in the preparation of biomaterials and polymeric compositions. Employing ethanol would have represented the predictable use of a known solvent to facilitate dissolution, mixing, and preparation of the composition while providing a reasonable expectation of success.
Regarding claim 13, Skoog et al. disclose the preparation of three-dimensional zirconium oxide hybrid scaffolds for tissue engineering using zirconium (IV) propoxide as the zirconium precursor. Skoog et al. teach that zirconium propoxide undergoes hydrolysis and condensation during the sol-gel process to form the zirconium oxide hybrid network, which is fabricated into three-dimensional scaffolds suitable for supporting cell adhesion and proliferation (See page 3, Zirconium oxide hybrid material synthesis and film preparation).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to utilize zirconium (IV) propoxide as the zirconium source in the regenerative composition of the combined prior art because Skoog et al. teach that zirconium (IV) propoxide is a suitable precursor for forming biocompatible zirconium oxide hybrid scaffolds for tissue engineering. One of ordinary skill in the art would have reasonably expected that employing zirconium propoxide would provide a robust inorganic-organic network with desirable mechanical strength and biocompatibility for tissue regeneration applications.
Regarding claim 16, Sharif et al. teaches the preparation of stable zirconium chelate solutions by combining a zirconium compound with an alpha-hydroxy carboxylic acid or a salt thereof (See Abstract and claim 1). Sharif et al. discloses that the alpha-hydroxy carboxylic acid-to-zirconium molar ratio may range from 0.5:1 to 20:1. Sharif et al. further identifies citrate, tartrate, and malate zirconium chelates, thereby teaching carboxylic acid components corresponding to the claimed first element (See claim 1).
The claimed zirconium-to-first-element molar ratio of 0.35 to 0.40 corresponds, when expressed in the inverse form, to a first-element-to-zirconium molar ratio of approximately 2.5:1 to 2.86:1. The acid-to-zirconium range expressly disclosed by Sharif et al. encompasses this claimed range.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to select an acid-to-zirconium molar ratio within the expressly disclosed range, including approximately 2.5:1 to 2.86:1, when preparing the zirconium-containing composition of the combined prior art. Such a selection would have resulted in a zirconium-to-first-element molar ratio of 0.35 to 0.40 as required by claim 16, with a reasonable expectation of obtaining a stable zirconium carboxylate-containing composition.
Regarding claim 17, Indira et al. disclose the synthesis of a biodegradable citrate-based polyester using citric acid (CA), 1,6-hexanediol (HD), and sebacic acid (SeA) in a 1:1:1 molar ratio, respectively. Thus, Indira et al. expressly teaches a 1:1 molar ratio between the first element (citric acid) and the second element (1,6-hexanediol), which falls within the claimed range of between 1 and 3 (See page 2, synthesis of polyester and preparation of nano-hydroxyapatite polymer composite).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to employ a molar ratio of the first and second elements within the claimed range because Indira et al. teach that such a ratio is suitable for preparing biodegradable polyester materials having desirable mechanical properties, biodegradability, and biocompatibility for tissue engineering applications. One of ordinary skill in the art would have reasonably expected that employing the disclosed molar ratio would produce a suitable polymeric network for tissue regeneration with predictable results.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Yang et al. (US8911720B2), in view of Djuric et al. (US20120053303A1).
Regarding claim 18, Yang et al. disclose citrate-based polyester biomaterials prepared by polycondensation of citric acid, corresponding to the claimed first element, with a diol having at least two hydroxyl groups, corresponding to the claimed second element. Yang et al. further discloses that the resulting poly (diol citrate) materials are suitable for biomedical and tissue-engineering applications (See Abstract, claim 1, and summary of the invention, paragraph 2). However, Yang et al. do not expressly disclose that the molar ratio between the first and second elements is between 1.8 and 2.2.
Djuric et al. discloses branched polyesters obtained by polycondensation of citric acid with at least one polyalcohol having at least two hydroxyl groups. Djuric et al. expressly teaches that the molar ratio of citric acid to the polyalcohol may range from 2.4:1 to 1:3, preferably from 2.4:1 to 1:2.4, and more preferably from 2:1 to 1:2 (See paragraph 0016). The expressly disclosed ranges encompass the claimed first-element-to-second-element molar ratio of 1.8 to 2.2. Djuric et al. further identifies suitable diols including 1,8-octanediol and 1,12-dodecanediol.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to prepare the citrate-based polyester system of Yang et al. using a citric-acid-to-diol molar ratio within the range expressly taught by Djuric et al., including a ratio between 1.8 and 2.2. one of ordinary skill in the art would have been motivated to make this selection because the secondary reference teaches the same polyester-forming reaction between citric acid and hydroxyl-containing polyalcohols and expressly identifies the disclosed molar ratios as suitable for producing citric-acid-based-polyesters. The skilled artisan would therefore have had a reasonable expectation of successfully preparing Yang et al.’s citrate-based polyester using the claimed molar ratio.
Regarding claim 19, Lapuente Fernandez et al. disclose a process for obtaining a composition suitable for tissue regeneration or reconstruction, including bone tissue regeneration, as discussed with respect to claim 1. Slota et al. teach that such compositions may further function as carriers for transporting and/or releasing pharmaceutical nutraceutical, and cosmetic active ingredients. Leblanc et al. and Lupu-Haber et al. further teach zirconium containing scaffold materials for tissue engineering applications, while Weng et al. disclose zirconia-containing bone scaffolds exhibiting improved biological performance.
Indira et al. disclose preparing biodegradable polyester compositions by combining citric acid, 1,6-hexanediol, and sebacic acid followed by heating through melt polycondensation to produce a polyester suitable for tissue engineering applications, thereby teaching the step of heating the reaction mixture to obtain a polymer or polyester.
Skoog et al. disclose preparing zirconium containing hybrid materials by first preparing separate precursor solutions, followed by sequential mixing of the zirconium-containing precursor solution with the remaining components prior to formation of the final hybrid network. Thus, Skoog et al. teach sequential mixing of the components before polymer formation.
Sharif et al. teaches the preparation of stable zirconium chelate solutions by combining a zirconium compound with an alpha-hydroxy carboxylic acid or a salt thereof (See Abstract and claim 1). Sharif et al. discloses that the alpha-hydroxy carboxylic acid-to-zirconium molar ratio may range from 0.5:1 to 20:1. Sharif et al. further identifies citrate, tartrate, and malate zirconium chelates, thereby teaching carboxylic acid components corresponding to the claimed first element (See claim 1).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the process of Lapuente Fernandez et al. by employing the sequential mixing techniques taught by Skoog et al. and Sharif et al., followed by the heating step taught by Indira et al., to obtain a polyester suitable for tissue regeneration. One of ordinary skill in the art would have been motivated to perform the components in a controlled sequence because the cited references teach that sequential addition and controlled precursor ratios promote uniform hydrolysis, condensation, polymerization, and formation of mechanically stable, biocompatible materials. Furthermore, it would have been obvious to employ a zirconium-to-first element molar ratio within the claimed range because Sharif et al. recognize that this stoichiometric relationship is an important synthesis parameter affecting formation of the zirconium-containing network, with a reasonable expectation of success.
Regarding claim 20, Cheng et al. disclose preparing solutions by dissolving components in ethanol, thereby teaching dissolution of a component in a solvent prior to further processing. Sharif et al. teaches the preparation of stable zirconium chelate solutions by combining a zirconium compound with an alpha-hydroxy carboxylic acid or a salt thereof (See Abstract and claim 1). Sharif et al. discloses that the alpha-hydroxy carboxylic acid-to-zirconium molar ratio may range from 0.5:1 to 20:1. Sharif et al. further identifies citrate, tartrate, and malate zirconium chelates, thereby teaching carboxylic acid components corresponding to the claimed first element (See claim 1).
Skoog et al. likewise disclose sequential preparation and mixing of precursor solutions prior to formation of the zirconium-containing hybrid material. Indira at al. disclose heating the reaction mixture during polyester synthesis to produce a biodegradable polyester suitable for tissue engineering applications.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to first dissolve the first element in a suitable solvent, combine the resulting solution with the zirconium precursor, heat the mixture to obtain a stable and homogenous precursor solution, and subsequently introduce the second component, because the cited references teach that controlled dissolution, sequential addition of reactants, and heating promote uniform hydrolysis, condensation, polymerization, and formation of homogenous zirconium-containing polyester materials. One of ordinary skill in the art would have had a reasonable expectation of success in employing these well-known processing steps to prepare a composition suitable for tissue regeneration and controlled delivery applications.
Regarding claim 20, the cited references teach preparation of homogeneous zirconium-containing precursor solutions through controlled mixing and heating during synthesis. The selection of a heating temperature sufficient to obtain a stable and homogenous solution is recognized in the art as a process parameter that affects hydrolysis, condensation, and polymer formation. In the absence of evidence that the claimed temperature range of 40°C to 100° is critical or produces unexpected results, it would have been obvious to one of ordinary skill in the art to optimize the heating temperature through routine experimentation to obtain a stable and homogeneous solution with a reasonable expectation of success.
In re Aller, where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges by routine experimentation is ordinarily within the skill of the art.
Regarding claim 21, Lapuente Fernandez et al. disclose compositions useful in regenerative medicine and tissue repair. Specifically, Lapuente Fernandez et al. teach compositions for tissue regeneration and reconstruction, including regeneration of bone tissue, cartilaginous tissue, and other mammalian tissues, thereby teaching the use of the composition for tissue regeneration and reconstruction.
Slota et al. disclose biologically safe carrier systems capable of transporting and releasing pharmaceutical, nutraceutical, and cosmetic active ingredients. Slota et al. further teach that such carrier systems are useful for controlled delivery of bioactive molecules in biomedical applications.
Leblanc et al. disclose scaffold biomaterials for bone tissue engineering and teach that such scaffold materials provide an alternative to conventional bone grafts for regenerating bone defects. Leblanc et al. further teach that scaffold biomaterials May serve as carriers for biologically active agents while promoting tissue regeneration.
Lupu-Haber et al, disclose zirconium oxide/PLGA composite scaffolds for bone tissue engineering, wherein the scaffolds are designed to deliver bone morphogenetic protein-2 (BMP-2) to promote bone regeneration, thereby teaching both tissue regeneration and controlled delivery of therapeutic agents.
Weng et al. disclose zirconia-containing hydroxyapatite scaffolds exhibiting improved biological performance and mechanical properties for bone tissue engineering, demonstrating the suitability of zirconium-containing scaffold materials for regenerative biomedical applications.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to utilize the regenerative composition of Lapuente Fernandez et al., as modified by the teachings of Slota et al., Leblanc et al., Lupu-Haber et al., and Weng et al., for the treatment of tissue regeneration or reconstruction and as a carrier for pharmaceutical, nutraceutical, and cosmetic active ingredients because each reference teaches complementary aspects of regenerative biomaterials and controlled delivery systems. One of ordinary skill in the art would have been motivated to combine these teachings to provide a multifunctional biomaterial capable of promoting tissue repair while simultaneously delivering bioactive agents, with a reasonable expectation of success.
With respect to the recited diagnostic and/or theragnostic purposes and applications to cardiovascular, muscular, epidermal/skin, or nervous system tissues, these recitations are directed primarily to intended uses of the claimed composition. the prior art teaches that the disclosed biomaterials are suitable for regenerative medicine and tissue engineering applications, and the particular tissue selected for treatment would have been an obvious matter of clinical application depending on the tissue requiring repair, absent evidence that the claimed composition is structurally different or uniquely adapted for those specific tissues.
Conclusion
No claim is allowed.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A. Wax, can be reached at telephone number (571) 272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KIMBERLY BARBER/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
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