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 .
Withdrawn Claim Rejections
The rejections of:
Claim 1 under 35 U.S.C. 102(a)(1) as being anticipated by Zussman (US 20090074832 A; of record);
Claims 1-2, 5-6, 11 and 17-22 under 35 U.S.C. 103 over Zussman (US 20090074832 A; of record);
Claims 1-2, 5-6, 11 and 17-20 under 35 U.S.C. 103 as being unpatentable over Zussman (US 20090074832 A; of record) as applied to claims 1-2, 5-6, 11 and 17-20 above, and further in view of Kastogiannis (Kastogiannis, Konstantinos Alexandros G., GoranT., Vladisavljevi¢, and Stella Georgiadou. "Porous electrospun polycaprolactone (PCL) fibres by phase separation.” European Polymer Journal 69 (2015): 284-295; of record); and
Claims 17-20 under 35 U.S.C. 103 over Chou (Chou, Shih-Feng, and Kim A Woodrow. “Relationships between mechanical properties and drug release from electrospun fibers of PCL and PLGA blends.” Journal of the mechanical behavior of biomedical materials vol. 65 (2017): 724-733; doi:10.1016/j.jmbbm.2016.09.004.; of record), in view of Jang et al. (Macromol. Res. 20, 12, 1234-1242)
are hereby withdrawn in view of the claim amendments filed on 7/22/25; specifically, amending “comprises” to “is”.
New Claim Rejections - 35 USC § 112(d)
Applicant' s claim amendments have necessitated the following new grounds of rejection.
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 19-20 is 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 19 recites the limitation "the polylactic acid" in line 2; “the poly(lactic-co-glycolic acid)” in line 3; “the polyethylene glycol” in line 5; “the poly(p-dioxanone)” in line 7; and “the polycaprolactone” in line 9. Claim 19 depends from claim 17, which as amended, no longer recites these species There is insufficient antecedent basis for this limitation in the claim.
Claim 20 recites the limitation “the poly(lactic-co-glycolic acid) copolymer” and “the polycaprolactone” in line 2. Claim 20 depends from claim 17, which as amended, no longer recites these species. There is insufficient antecedent basis for this limitation in the claim.
New Claim Rejections - 35 USC § 112(d)
Applicant' s claim amendments have necessitated the following new grounds of rejection.
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.
Claim 19 is 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. The recitation of additional polymers not currently listed in the Markush group of the biodegradable polymer of instant, independent claim 17 makes claim 19 broader. 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.
New Claim Rejections - 35 USC § 103
Applicant' s claim amendments have necessitated the following new grounds of rejection.
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 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(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 1-2, 5-6, 11 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Patel et al. (WO 2012/078472; published: 6/14/12), in view of Clay (US 2014/0199362; published: 7/17/14).
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
Patel et al. is directed to fibrous polymer scaffolds having diametrically patterned polymer fibers (Title).
With regards to instant claim 1, Patel et al. teach the production of fibrous scaffold having randomly oriented fibers made using poly(L-lactide-co-caprolactone) with poly(propylene glycol) (Example 4). Patel et al. teach that several embodiments, a molecule is covalently attached, either directly or through a linker, to the fibrous polymer scaffolds, and the molecule is capable of either covalently or non-covalently attaching to a member selected from an extracellular matrix component, a growth factor, a differentiation factor and combinations thereof ([00176]).
With regards to instant claim 2, Patel et al. teach that the polymer fibers have an average fiber diameter of, for example, between 10 and 1,000 nm (i.e., between 0.01 and 1 µm) (overlapping ranges with the claimed range) ([00142]).
With regards to instant claims 5-6, Patel et al. teach that the fibers comprise a copolymer of L-lactide and epsilon-caprolactone, with molar ratios of L-lactide between 40%-90%, and molar ratios of epsilon-caprolactone between 10%-60% (e.g., 50% and 50%) (overlapping ranges with the claimed range) ([00103]). Patel teach that higher molecular weights often means a slower degradation rate ([0096]). Examiner notes that claims 5-6 depend on claims 1-2, which only requires one of the two polymers listed in the Markush grouping recited in instant claims 5-6. Claims 5-6 merely narrows the molar ratio and/or molecular weight of each of the species in the Markush grouping of claim 1, which does not change the requirement of only one of polymer species being present in the composition.
With regards to instant claim 11, Patel et al. teach a fiber comprises two, three, four or five different polymers or subunits which are members selected from aliphatic polyesters, polyhydroxyalkanoates, polyurethanes, poly(ester urethane), poly(ether urethane), poly(trimethylene carbonate), poly(glycerol sebacate), poly (pyrrole), poly(acetylene), polyalkylene oxides, polydimethylsiloxane, polyvinylalcohol, polyvinylpyrrolidone, polylysine, collagen, gelatin, laminin, fibronectin, elastin, alginate, fibrin, hyaluronic acid, proteoglycans, polypeptides, polysaccharides, silk fibroin and combinations and copolymers thereof ([0088]-[0091]). In formulating a desired fiber diameter, one should consider whether any components (i.e., drugs, growth factors, differentiation factors, etc.) will be seeded between fibers and/or the size of any cells expected to be attracted to and deposited along the fibers in vivo ([00145]). Patel et al. also teach that several embodiments, a molecule is covalently attached, either directly or through a linker, to the fibrous polymer scaffolds, and the molecule is capable of either covalently or non-covalently attaching to a member selected from an extracellular matrix component, a growth factor, a differentiation factor and combinations thereof ([00176]). The growth factor is selected from acidic fibroblast growth factor, basic fibroblast growth factor, nerve growth factor, brain-derived neurotrophic factor, insulin-like growth factor, platelet derived growth factor, transforming growth factor beta, vascular endothelial growth factor, epidermal growth factor, keratinocyte growth factor and combinations thereof ([00176]).
With regards to instant claim 21, Patel et al. teach that the fiber diameters can vary both between and within layers. In some embodiments, the fiber diameters can vary from 1nm - 10,000nm ([00142]). In some embodiments, the fiber diameters can vary from 100nm - 2000nm ([00142]). Different fiber diameters may be desirable for different applications. In formulating a desired fiber diameter, one should consider whether any components (i.e., drugs, growth factors, differentiation factors, etc.) will be seeded between fibers and/or the size of any cells expected to be attracted to and deposited along the fibers in vivo ([00142]).
Ascertainment of the Difference Between the Scope of the Prior Art and Claims
(MPEP §2141.012)
Although Patel et al. do teach wherein an active agent such as a growth factor is incorporated into the composition, they do not specifically teach wherein the active material is dispersed in the biodegradable polymer fiber of the composition, as required by instant claim 1. Although Patel et al. do teach wherein the biodegradable polymer fiber is poly(L-lactide-co-caprolactone), they do not teach wherein the fiber porosity is between 65 and 90% and the molecular weight is between 35,000 and 85,000 Da as required by instant claims 2, 5-6 and 21. Although Patel et al. list gelatin as one among others as a second, third, fourth or fifth polymer that can be incorporated in its compositions, they do not indicate that gelatin should be incorporated in an amount from 1 to 10 wt% of the biodegradable polymer fiber, as required by instant claim 11. However, these deficiencies are cured by Clay.
Clay is directed to biodegradable polymer fiber delivery system for active agents (Abstract). Clay teaches an implantable fiber comprising an active agent (e.g., clonidine hydrochloride) in an amount ranging from about 0.1 to about 0.3 wt% of the fiber and the implantable fiber comprising at least one biodegradable polymer comprising poly(L-lactide-co-caprolactone) (i.e., the same biodegradable polymer taught by Patel et al.) ([0008]). Clay teaches that in order to make such composition, a solution of solvent, biocompatible polymer and clonidine and/or other therapeutic agent(s) in a dissolved or dispersed form is placed in a mold of the desired size and shape and such results in a polymeric fiber region containing these species after solvent removal ([0157]). With regards to the fiber porosity, Clay teaches a porosity of at least about 30%, at least about 50%, at least about 60%, at least about 70%, at least about 90% and that the pore enhances release of the clonidine and may support ingrowth of cells, formation or remodeling of bone, cartilage and/or vascular tissue ([0106]). With regards to the polymer molecular weight, Clay teaches that the fiber comprises a polymer having an average molecular weight of the polymer can be from about 1000 to about 10,000,000 Da; or about 20,000 Da to 50,000 Da and furthermore, teach that higher MW polymers will degrade faster than lower MW polymers
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
Patel et al. and Clay are both directed to biodegradable fibers comprising poly(L-lactide-co-caprolactone) for use pharmaceutically. Based on these teachings, it would have been prima facie obvious to one of ordinary skill in the art, before the invention was effectively filed, to modify the polymeric fibers of Patel et al. by dispersing active agents (e.g., growth factors) into the fibers to achieve the predictable result of obtaining a composition suitable for drug delivery. One of ordinary skill in the art would have been motivated to do so because Clay teach that it is advantageous for providing a composition capable of releasing an active agent over a period of multiple days; for example, the fiber can have pores that allow release of the drug from the fiber ([0027]).
The porosity and molecular weight of poly(L-lactide-co-caprolactone) in the fibers of Patel et al. are clearly result effective parameters that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and would reasonably expect success. It would have been customary for an artisan of ordinary skill to determine the optimal porosity of the polymer in order to best achieve the desired results as such would provide advantageous release of the clonidine (or other therapeutic agent) and may support ingrowth of cells, formation or remodeling of bone, cartilage and/or vascular tissue, as taught by Clay ([0106]). Furthermore, it would have been customary for an artisan of ordinary skill to determine the optimal polymer molecular weight in order to best achieve the desired results as such would provide advantageous degradation as taught by Clay ([0131]), which in turn affect the release kinetics of therapeutics agents. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to engage in routine experimentation to determine optimal or workable ranges that produce expected results. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F. 2d 454, 105 USPQ 233 (CCPA 1955).
Regarding the concentration of gelatin and/or growth factor as specified in claim 11, MPEP 2144.05 states:
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Furthermore, Clay teaches an implantable fiber comprising an active agent (e.g., clonidine hydrochloride) in an amount ranging from about 0.1 to about 0.3 wt% of the fiber and the implantable fiber comprising at least one biodegradable polymer comprising poly(L-lactide-co-caprolactone) (i.e., the same biodegradable polymer taught by Patel et al.) ([0008]). Clay teaches that gelatin provides sustained release of active agents and viscosity enhancing actions ([0091] and [0132]). The Applicants' specification provides no evidence that the selected concentration range in claim 11 was not due to routine optimization and/or that the results should be considered unexpected compared to the prior art. Due to numerous physical/chemical/biological properties of various chemicals (e.g., desired release profile, desired viscosity, needed amount of growth factors dependent on disease state/age/sex/weight of patient), it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine these teachings and alter the concentration. One of ordinary skill in the art would have been motivated to change the concentration as this could be expected to be advantageous for providing the desirable biological effect (from the growth factors) and release profile (from the polymeric fibers). Furthermore, The Examiner considers it prima facie obvious to optimize the amounts of any biologically active agent to achieve their known biological effect, absent unexpectedly superior properties of the claimed invention.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the invention was effectively filed, as evidenced by the references, especially in the absence of evidence to the contrary.
Thus, the claimed invention was prima facie obvious before the effective filing date of the claimed invention.
Claims 17-20 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Patel et al. (WO 2012/078472; published: 6/14/12) and Clay (US 2014/0199362; published: 7/17/14). as applied to claims 1-2, 5-6, 11 and 21 above, and further in view of Kim et al. (Biomaterials, 2003, 24 (27), 4977-4985).
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
Patel et al. is directed to fibrous polymer scaffolds having diametrically patterned polymer fibers (Title).
With regards to instant claims 1 and 17, Patel et al. teach the production of fibrous scaffold having randomly oriented fibers made using poly(L-lactide-co-caprolactone) with poly(propylene glycol) (Example 4). Patel et al. teach that several embodiments, a molecule is covalently attached, either directly or through a linker, to the fibrous polymer scaffolds, and the molecule is capable of either covalently or non-covalently attaching to a member selected from an extracellular matrix component, a growth factor, a differentiation factor and combinations thereof ([00176]).
With regards to instant claims 2, 18 and 22, Patel et al. teach that the polymer fibers have an average fiber diameter of, for example, between 10 and 1,000 nm (i.e., between 0.01 and 1 µm) (overlapping ranges with the claimed range) ([00142]).
With regards to instant claims 5-6 and 19, Patel et al. teach that the fibers comprise a copolymer of L-lactide and epsilon-caprolactone, with molar ratios of L-lactide between 40%-90%, and molar ratios of epsilon-caprolactone between 10%-60% (e.g., 50% and 50%) (overlapping ranges with the claimed range) ([00103]). Patel teach that higher molecular weights often means a slower degradation rate ([0096]). Examiner notes that claims 5-6 depend on claims 1-2, which only requires one of the two polymers listed in the Markush grouping recited in instant claims 5-6. Claims 5-6 merely narrows the molar ratio and/or molecular weight of each of the species in the Markush grouping of claim 1, which does not change the requirement of only one of polymer species being present in the composition.
With regards to instant claims 11 and 17, Patel et al. teach a fiber comprises two, three, four or five different polymers or subunits which are members selected from aliphatic polyesters, polyhydroxyalkanoates, polyurethanes, poly(ester urethane), poly(ether urethane), poly(trimethylene carbonate), poly(glycerol sebacate), poly (pyrrole), poly(acetylene), polyalkylene oxides, polydimethylsiloxane, polyvinylalcohol, polyvinylpyrrolidone, polylysine, collagen, gelatin, laminin, fibronectin, elastin, alginate, fibrin, hyaluronic acid, proteoglycans, polypeptides, polysaccharides, silk fibroin and combinations and copolymers thereof ([0088]-[0091]). In formulating a desired fiber diameter, one should consider whether any components (i.e., drugs, growth factors, differentiation factors, etc.) will be seeded between fibers and/or the size of any cells expected to be attracted to and deposited along the fibers in vivo ([00145]). Patel et al. also teach that several embodiments, a molecule is covalently attached, either directly or through a linker, to the fibrous polymer scaffolds, and the molecule is capable of either covalently or non-covalently attaching to a member selected from an extracellular matrix component, a growth factor, a differentiation factor and combinations thereof ([00176]). The growth factor is selected from acidic fibroblast growth factor, basic fibroblast growth factor, nerve growth factor, brain-derived neurotrophic factor, insulin-like growth factor, platelet derived growth factor, transforming growth factor beta, vascular endothelial growth factor, epidermal growth factor, keratinocyte growth factor and combinations thereof ([00176]).
With regards to instant claim 20, the Examiner notes that as indicated above, the claim is broader than the independent claim as it recites polymers not recited in claim 17.
With regards to instant claims 21 and 22, Patel et al. teach that the fiber diameters can vary both between and within layers. In some embodiments, the fiber diameters can vary from 1nm - 10,000nm ([00142]). In some embodiments, the fiber diameters can vary from 100nm - 2000nm ([00142]). Different fiber diameters may be desirable for different applications. In formulating a desired fiber diameter, one should consider whether any components (i.e., drugs, growth factors, differentiation factors, etc.) will be seeded between fibers and/or the size of any cells expected to be attracted to and deposited along the fibers in vivo ([00142]).
Ascertainment of the Difference Between the Scope of the Prior Art and Claims
(MPEP §2141.012)
Although Patel et al. do teach wherein an active agent such as a growth factor is incorporated into the composition, they do not specifically teach wherein the active material is dispersed in the biodegradable polymer fiber of the composition, as required by instant claims 1 and 17. Although Patel et al. do teach wherein the biodegradable polymer fiber is poly(L-lactide-co-caprolactone), they do not teach wherein the fiber porosity is between 65 and 90% and the molecular weight is between 35,000 and 85,000 Da as required by instant claims 2, 5-6, 18 and 21-22. Although Patel et al. list gelatin as one among others as a second, third, fourth or fifth polymer that can be incorporated in its compositions, they do not indicate that gelatin should be incorporated in an amount from 1 to 10 wt% of the biodegradable polymer fiber, as required by instant claims 11 and 17. However, these deficiencies are cured by Clay.
Clay is directed to biodegradable polymer fiber delivery system for active agents (Abstract). Clay teaches an implantable fiber comprising an active agent (e.g., clonidine hydrochloride) in an amount ranging from about 0.1 to about 0.3 wt% of the fiber and the implantable fiber comprising at least one biodegradable polymer comprising poly(L-lactide-co-caprolactone) (i.e., the same biodegradable polymer taught by Patel et al.) ([0008]). Clay teaches that in order to make such composition, a solution of solvent, biocompatible polymer and clonidine and/or other therapeutic agent(s) in a dissolved or dispersed form is placed in a mold of the desired size and shape and such results in a polymeric fiber region containing these species after solvent removal ([0157]). With regards to the fiber porosity, Clay teaches a porosity of at least about 30%, at least about 50%, at least about 60%, at least about 70%, at least about 90% and that the pore enhances release of the clonidine and may support ingrowth of cells, formation or remodeling of bone, cartilage and/or vascular tissue ([0106]). With regards to the polymer molecular weight, Clay teaches that the fiber comprises a polymer having an average molecular weight of the polymer can be from about 1000 to about 10,000,000 Da; or about 20,000 Da to 50,000 Da and furthermore, teach that higher MW polymers will degrade faster than lower MW polymers.
Patel et al. and Clay do not teach wherein the biodegradable polymer forming the fibers is either PLA-b-PEG-b-PLA or a combination of PLA-b-PEG-b-PLA and poly(L-lactide-co-caprolactone) wherein such fiber has a diameter of 0.1-3 µm and a porosity of 65-90%, as required by instant claims 17-18. However, such deficiency is cured by Kim et al.
Kim et al. is directed to the control of degradation rate and hydrophobicity in electrospun non-woven poly(D,L-lactide) nanofiber scaffolds for biomedical applications (Title). Kim et al. teach an electrospun scaffold containing four compositions (40 wt% HMW PLA, 15 wt% of lactide, 20 wt% of PLA-b-PEG-b-PLA and 25 wt% of lower molecular weight PLGA), which exhibited an ideal biodegradation profile, good hydrophilicity, and stable mechanical properties in aqueous conditions suitable for two specific biomedical applications including biodegradable scaffolds for tissue engineering and prevention of post-operative adhesions (Conclusion section). All electrospun non-woven scaffolds exhibited sub-micron sized fiber diameters, ranging from 500 to 800 nm, and about 0.3–0.4 g/cm3 of density or a porosity 70–75% (Conclusion section).
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
Patel et al. and Clay are both directed to biodegradable fibers comprising poly(L-lactide-co-caprolactone) for use pharmaceutically. Based on these teachings, it would have been prima facie obvious to one of ordinary skill in the art, before the invention was effectively filed, to modify the polymeric fibers of Patel et al. by dispersing active agents (e.g., growth factors) into the fibers to achieve the predictable result of obtaining a composition suitable for drug delivery. One of ordinary skill in the art would have been motivated to do so because Clay teach that it is advantageous for providing a composition capable of releasing an active agent over a period of multiple days; for example, the fiber can have pores that allow release of the drug from the fiber ([0027]).
The porosity and molecular weight of poly(L-lactide-co-caprolactone) and PLA-b-PEG-b-PLA in the fibers of Patel et al. are clearly result effective parameters that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and would reasonably expect success. It would have been customary for an artisan of ordinary skill to determine the optimal porosity of the polymer in order to best achieve the desired results as such would provide advantageous release of the clonidine (or other therapeutic agent) and may support ingrowth of cells, formation or remodeling of bone, cartilage and/or vascular tissue, as taught by Clay ([0106]). Furthermore, it would have been customary for an artisan of ordinary skill to determine the optimal polymer molecular weight in order to best achieve the desired results as such would provide advantageous degradation as taught by Clay ([0131]), which in turn affect the release kinetics of therapeutics agents. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to engage in routine experimentation to determine optimal or workable ranges that produce expected results. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F. 2d 454, 105 USPQ 233 (CCPA 1955).
Regarding the concentration of gelatin and/or growth factor as specified in claim 11, MPEP 2144.05 states:
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Furthermore, Clay teaches an implantable fiber comprising an active agent (e.g., clonidine hydrochloride) in an amount ranging from about 0.1 to about 0.3 wt% of the fiber and the implantable fiber comprising at least one biodegradable polymer comprising poly(L-lactide-co-caprolactone) (i.e., the same biodegradable polymer taught by Patel et al.) ([0008]). Clay teaches that gelatin provides sustained release of active agents and viscosity enhancing actions ([0091] and [0132]). The Applicants' specification provides no evidence that the selected concentration range in claim 11 was not due to routine optimization and/or that the results should be considered unexpected compared to the prior art. Due to numerous physical/chemical/biological properties of various chemicals (e.g., desired release profile, desired viscosity, needed amount of growth factors dependent on disease state/age/sex/weight of patient), it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine these teachings and alter the concentration. One of ordinary skill in the art would have been motivated to change the concentration as this could be expected to be advantageous for providing the desirable biological effect (from the growth factors) and release profile (from the polymeric fibers). Furthermore, The Examiner considers it prima facie obvious to optimize the amounts of any biologically active agent to achieve their known biological effect, absent unexpectedly superior properties of the claimed invention.
Based on these teachings, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to combine two compositions, each of which is taught by the prior art to be useful for the same purpose (combining fibers comprising poly(L-lactide-co-caprolactone of Patel et al. and fibers comprising PLA-b-PEG-b-PLA of Kim et al. for the purpose of providing a composition suitable for biomedical applications such as tissue repair), in order to form a third composition to be used for the very same purpose (See MPEP 2144.06-I). Alternatively, based on these teachings, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to substitute equivalents, each of which is taught by the prior art to be useful for the same purpose (substituting fibers comprising poly(L-lactide-co-caprolactone of Patel et al. with fibers comprising PLA-b-PEG-b-PLA of Kim et al. for the purpose of providing a composition suitable for biomedical applications such as tissue repair) (See MPEP 2144.06-II).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the invention was effectively filed, as evidenced by the references, especially in the absence of evidence to the contrary.
Thus, the claimed invention was prima facie obvious before the effective filing date of the claimed invention.
Response to Arguments
Response to Arguments
Applicants’ arguments are moot in view of the new grounds of rejection.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GENEVIEVE S ALLEY whose telephone number is (571)270-1111. The examiner can normally be reached Monday-Friday 8:00-5:00.
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/GENEVIEVE S ALLEY/ Primary Examiner, Art Unit 1617