DETAILED ACTION
Status of Claims
Claims 1-20 are currently pending and are the subject of this Office Action. This is the first Office Action on the merits of the claims. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Office Action: Non-Final
Claim Rejections – 35 U.S.C. § 112 - Indefiniteness
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 2-3, 5, 13-14 and 16 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 pre-AIA , that applicant regards as the invention.
A. Claims 2 and 13 contain the trademark/trade name “bioglass.” Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. § 112, second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe “bioactive glass” and, accordingly, the identification/description is indefinite. Subsequent claim 3 depends on claim 2 and are thus, indefinite as well.
B. Claim 5 is drawn to:
5. ([…]) The sheet membrane of claim 4, wherein the mineral/ceramic from natural sources is selected from the group consisting of an organic bone material, natural carbonate apatite and a mixture containing carbonate apatite and one or more calcium-containing compounds.
and is indefinite for multiple uses of “and” and “or” in the recitation, “[…], natural carbonate apatite and a mixture containing carbonate apatite and one or more calcium-containing compounds,” thereby rendering the metes and bounds of the claim unclear. In this respect, it is unclear whether the combination of “a mixture containing carbonate apatite” and “one or more calcium-containing compounds” is one embodiment or multiple embodiments, which can be separately included.
C. Claim 14 is indefinite in the recitation, “the calcium phosphate compound.” There is insufficient antecedent basis for this limitation in the claim as no “calcium phosphate” is recited in claim 11 from which claim 14 depends. See MPEP § 2173.05(e).
D. Claim 16 is indefinite for similar reasons as discussed above for claim 5 in B..
Further clarification is required.
Claim Rejections - 35 U.S.C. § 112(d)- Not Further Limiting
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 35 U.S.C. § 112 (pre-AIA ), fourth paragraph:
Subject to the fifth paragraph of 35 U.S.C. 112 (pre-AIA )], 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 5 and 16 are rejected under 35 U.S.C. § 112(d) or 35 U.S.C. § 112 (pre-AIA ), 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.
A. Claim 5 is drawn to:
5. ([…]) The sheet membrane of claim 4, wherein the mineral/ceramic from natural sources is selected from the group consisting of an organic bone material, natural carbonate apatite and a mixture containing carbonate apatite and one or more calcium-containing compounds.
wherein the recitation for the embodiment, “a mixture containing carbonate apatite and one or more calcium-containing compounds,” is not further limiting. The claim appears to be drawn to be drawn to a Markush group with closed, “consisting of” transitional phrasing, while reciting an embodiment with open, “containing” transitional phrasing. See MPEP § 2111.03(I) stating, “[t]he transitional term “comprising”, which is synonymous with “including,” “containing,” or “characterized by,” is inclusive or open-ended and does not exclude additional, unrecited elements or method steps”; see MPEP § 2173.05(h) regarding Markush language. 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. In this respect, examiner suggests amending claim 5 to read:
5. ([…]) The sheet membrane of claim 4, wherein the mineral/ceramic from natural sources is selected from the group consisting of: (i) an organic bone material, (ii) natural carbonate apatite, and (iii) a mixture consisting of
B. Claim 16 is not further limiting for similar reasons as discussed above for claim 5 in A..
Further clarification is required.
Claim Rejections – 35 U.S.C. § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. § 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 8, 10-12 and 19 are rejected under 35 U.S.C. § 102(a)(1) as being anticipated by LI (US 2013/0004559 A1, Publ. Jan. 3, 2013; on 11/09/2023 IDS; hereinafter, “Li”).
Li is directed to:
FLAT SELF-CURLING PERMEABLE SHEET MEMBRANE
ABSTRACT
A flat self-curling permeable sheet membrane containing a matrix formed of crosslinked biopolymeric fibers. The matrix self-curls into a predetermined shape upon absorption of an aqueous fluid and is permeable to molecules having molecular weights not greater than 1x106 daltons. Also disclosed is a method of preparing such a flat self-curling permeable membrane.
Li, title & abstract. In this regard, Li discloses a claim embodiment drawn to “[f]lat self-curling permeable sheet membrane comprising a matrix formed of crosslinked biopolymeric fibers,” “wherein the biopolymeric fibers are collagen fibers,” and “further compris[es] a bioactive agent”:
1. A flat self-curling permeable sheet membrane comprising a matrix formed of crosslinked biopolymeric fibers, wherein the matrix self-curls into a predetermined shape upon absorption of an aqueous fluid, and is permeable to molecules having molecular weights not greater than 1×106 daltons.
2. The membrane of claim 1, wherein the matrix has a thickness of 0.2-1.2 mm, a density of 0.1-0.8 g/cm3, a hydrothermal shrinkage temperature of 50-85° C., a suture pullout strength of 0.1-3.0 kg, an in vivo resorption time of 2-18 months, a self-curling time of 10-80 seconds, a tensile strength of 50-300 kg/cm2, and a compression resistance of 0.1-10 N.
3. The membrane of claim 2, wherein the biopolymeric fibers are oriented.
4. The membrane of claim 2, wherein the biopolymeric fibers are collagen fibers.
[…]
6. The membrane of claim 3, further comprising a bioactive agent.
(Li, claims 1-4 and 6).
Regarding independent claims 1 and 11 and the requirements:
1. ([…]) A flat self-curling composite sheet membrane comprising a flat layer of collagen and a bioactive agent, wherein the flat layer self-curls into a predetermined shape upon absorption of an aqueous fluid.
[…]
11. ([…]) A flat self-curling composite sheet membrane consisting of a flat layer of collagen and a bioactive agent, wherein the flat layer self-curls into a predetermined shape upon absorption of an aqueous fluid.
Li clearly teaches a “[f]lat self-curling permeable sheet membrane comprising a matrix formed of crosslinked biopolymeric fibers,” “wherein the biopolymeric fibers are collagen fibers,” and “further compris[es] a bioactive agent” (Li, claims 1-4 and 6), WHEREBY it is noted
“[a] flat self-curling permeable sheet membrane comprising a matrix formed of crosslinked biopolymeric fibers” (Li, claims 1-3), “wherein the biopolymeric fibers are collagen fibers” (Li, claim 4) reads on:
a “flat layer of collagen” of claims 1 and 11,
“wherein the matrix self-curls into a predetermined shape upon absorption of an aqueous fluid” (Li, claim 1) reads on the requirements of claims 1 and 11 for “wherein the flat layer self-curls into a predetermined shape upon absorption of an aqueous fluid”;
“further compris[es] a bioactive agent” (Li, claim 6) reads on the requirements of claims 1 and 11 for a “bioactive agent” (see MPEP § 2112.01 stating that a chemical composition and its properties are inseparable, therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present).
It is further noted that Li’s claim embodiment recited in Li’s claims 1-4 and 6 contain no further required components besides “[a] flat self-curling permeable sheet membrane comprising a matrix formed of crosslinked biopolymeric fibers” and a “bioactive agent,” thereby reading on the closed “consisting of” requirements of claim 11.
Thus, Li anticipates claims 1 and 11.
Regarding claims 8 and 19, and the requirements:
8. ([…]) The sheet membrane of claim 1, wherein the collagen is selected from the group consisting of Type I collagen, Type III collagen and a mixture of Type I and Type III collagen.
[…]
19. ([…]) The sheet membrane of claim 11, wherein the collagen is selected from the group consisting of Type I collagen, Type III collagen and a mixture of Type I and Type III collagen.
Li teaches:
[0016] Type I collagen fibers are the preferred material for preparing the membranes of the present invention due to their biocompatibility and ease in accessing large quantities of the material from animal source. Other biopolymeric materials, which can be natural or synthetic, include but are not limited to, other types of collagen (e.g., type II to type XXI), elastin, fibrin, polysaccharide (e.g., chitosan, alginic acid, cellulose, and glycosaminoglycan), a synthetic analog of a biopolymer by genetic engineering techniques, or a combination thereof.
(Li, par. [0016]), which reads on the collagen types of claims 8 and 19.
Thus, Li anticipates claims 8 and 19.
Regarding claims 10 and 12, and the requirements:
10. ([…]) The sheet membrane of claim 1, wherein the predetermined shape is selected from the group consisting of a V, a tube, an arch and a channel.
[…]
12. ([…]) The sheet membrane of claim 11, wherein the predetermined shape is selected from the group consisting of a V, a tube, an arch and a channel.
Li teaches that “[t]he sheet membrane in a hydrated state is mechanically folded into a predetermined shape,” which appear to include a “V,” “tube,” “arch” and “channel”:
[0020] Subsequently, the sheet membrane is hydrated ( e.g., humidified in a humidification chamber) so that it can be easily folded into different shapes. The sheet membrane in a hydrated state is mechanically folded into a predetermined shape as shown in FIG. 1. If the membrane is made of oriented biopolymeric fibers, it is preferred that the shape follow, to the extent possible, the configuration of the pre-cut tubular membrane, which is circumferentially inward. The folded membrane is inserted into or wrapped around and fixed to a rigid metal/plastic mesh of a similar size and shape, before it is crosslinked using a crosslinking agent such as an aldehyde (e.g., formaldehyde vapor) to fix and preserve the predetermined shape. Other crosslinking agents with sufficient vapor pressure can also be used. Unreacted crosslinking agent can be removed by rinsing with water. The crosslinked membrane is hydrated ( e.g, humidifying or its equivalent) to facilitate its flattening. As an example, the hydrated membrane can be converted into a flat sheet by compressing it within two plates. Finally, the flat membrane is dried before use. The thus-obtained flat membrane self-curls into the predetermined shape upon absorption of an aqueous liquid.
PNG
media_image1.png
200
400
media_image1.png
Greyscale
(Li, par. [0020], Fig. 1), thereby reading on the requirements of claims 10 and 12.
Thus, Li anticipates claims 10 and 12.
Claim Rejections – 35 U.S.C. § 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 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 pre-AIA 35 U.S.C. § 103(a) 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 C.F.R. § 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, 4, 6, 8-13, 15, 17 and 19-20 are rejected under 35 U.S.C. § 103 as being unpatentable over LI (US 2013/0004559 A1, Publ. Jan. 3, 2013; on 11/09/2023 IDS; hereinafter, “Li”), in view of DU (Du.C., et al., Formation of calcium phosphate/collagen composites through mineralization of collagen matrix, J. Biomed. Mater. Res., 50 (Apr. 07, 2000) pp. 518-527; hereinafter, “Du”).
The teachings of Li, as set forth in the above rejection of claims 1, 8, 10-12 and 19 under 35 U.S.C. § 102 (a)(1) by Li, are hereby incorporated. Although Li teaches the incorporation of bioactive agents:
[0007] A bioactive agent can be included in the membrane of this invention to assist wound healing and tissue regeneration for functional recovery. Examples include but are not limited to growth factors ( e.g., platelet-derived growth factor, basic fibroblast growth factor, insulin-like growth factor, vascular endothelial growth factor, and nerve growth factor), cytokines (e.g., thrombopoietin and erythropoietin), glycosaminoglycans (e.g., hylauronic acid, chondroitin sulfate), polysaccharides (e.g., chitosan, alginic acid, and cellulose), glycoproteins (e.g., mucins and luteinizing hormone), cell adhesive molecules (e.g., laminins and fibronectins), antibiotics ( e.g., gentamycin, erythromycin, silver sulfadiazine, and tetracycline), anti-blood vessel stenosis agent (e.g., sinolimus and paclitaxel) and the like. The bioactive agent may be incorporated into the membrane via electrostatic interactions, physical or mechanical interactions, covalent bonding using crosslinking agents or light, a combination of the above, or via a spacer molecule that is well known in the art.
(Li, par. [0007]), Li, however, DOES NOT TEACH the particular incorporation of calcium phosphate materials, or amounts thereof, per the requirements of claims 2, 4, 6, 9, 13, 15, 17 and 20:
2. ([…]) The sheet membrane of claim 1, wherein the bioactive agent is a calcium phosphate-based mineral formed of calcium sulfate, bioglass or a calcium phosphate compound.
[…]
4. ([…]) The sheet membrane of claim 1, wherein the bioactive agent is a mineral/ceramic from natural sources or is synthetically derived.
[…]
6. ([…]) The sheet membrane of claim 4, wherein the synthetically derived mineral/ceramic is selected from the group consisting of synthetically derived β-TCP (tricalcium phosphate), hydroxyapatite, biphasic mineral and calcium containing compounds.
[…]
9. ([…]) The sheet membrane of claim 1, wherein the ratio of collagen to bioactive agent is within the range of 30:70 to 5:95.
[…]
13. ([…]) The sheet membrane of claim 11, wherein the bioactive agent is a calcium phosphate-based mineral formed of calcium sulfate, bioglass or a calcium phosphate compound.
[…]
15. ([…]) The sheet membrane of claim 11, wherein the bioactive agent is a mineral/ceramic from natural sources or is synthetically derived.
[…]
17. ([…]) The sheet membrane of claim 15, wherein the synthetically derived mineral/ceramic is selected from the group consisting of synthetically derived β-TCP (tricalcium phosphate), hydroxyapatite, biphasic mineral and calcium containing compounds.
[…]
20. ([…]) The sheet membrane of claim 11, wherein the ratio of collagen to bioactive agent is within the range of 30:70 to 5:95.
Based on the state of the art, an artisan of ordinary skill would have found each of these features obvious.
Du, for instance, is directed to:
Formation of calcium phosphate/collagen composites through mineralization of collagen matrix
Abstract: Several types of calcium phosphate/collagen composites, including noncrystalline calcium phosphate/collagen, poorly crystalline carbonate-apatite (PCCA)/collagen, and PCCA + tetracalcium phosphate/collagen composites, were prepared through the mineralization of collagen matrix. The type I collagen was presoaked with a PO
PNG
media_image2.png
16
13
media_image2.png
Greyscale
containing solution and then immersed in a Ca2+ containing solution to allow mineral deposition. The solution of 0.56M sodium dibasic phosphate (Na2HPO4) with a pH of nearly 14 was metastable and its crystallization produced Na2HPO4 and sodium tripolyphosphate hexahydrate (Na5P3O10·• 6H2O), leading to a controlled release of orthophosphate ions during the subsequent mineral precipitation. The development of the composites was investigated in detail. The mineral contributed up to 60–70% of the weight of the final composites. The strength and Young's modulus of the composites in tensile tests overlapped the lower range of values reported for bone. When implanted in muscle tissue, the composite showed biodegradability that was partly through a multinucleated giant cell mediated process. In a bone-explant culture model it was observed that bone-derived cells deposited mineralizing collagenous matrix on the composite.
Du, title & abstract. In this regard, Du teaches “Type I collagen sheets” mineralized with CaCl2 and Na2HPO4 for obtaining calcium phosphate/collagen composites:
Type I collagen sheets sold commercially for use as a hemostatic sponge (Gelfixt®, Euroresearch s.r.l., Milano, Italy) were cut with a sharp razor. The mineralizing solutions named A, B, and C were prepared by dissolving the appropriate amount of salts in distilled water. Solution A was 1.12M calcium chloride (CaCl2). Solution B was 0.56M sodium dibasic phosphate (Na2HPO4) with a pH of nearly 14 adjusted by the addition of sodium hydroxide (NaOH). The preparation of solution B required heating in a water bath at 60°C. Preliminary experiments showed that solution B was metastable at room temperature. Solution C was 0.28M Na2HPO4 diluted from solution B. The composite was synthesized as follows through a two-stage reaction procedure called the B + A process. The collagen sheets were presoaked in solution B for 2 min at the collagen:solution ratio of 1:37 (w/v). Then the sheets were immersed in solution A at the collagen:solution ratio of 1:100 (w/v) and incubated at room temperature for 5, 10, 15, 30, and 40 min, and 1, 2, and 5 h. After the incubation for the selected period of time, the collagen sheets were washed thoroughly in distilled water to remove unreacted chemicals and by-products and loosely adherent minerals. The composites were lyophilized and weighed. The weight percentage of collagen in the composite was calculated and used to monitor the reaction. Control samples were prepared by changing the solution type and reaction sequence. These procedures were named A + B, C + A, and A + C processes. All these procedures used an extremely high initial Ca/P ratio. For the reasons demonstrated below, a B + A' process was performed that was similar to the B + A process except that the ratio of the collagen:solution A was 1:31 (w/v). In addition, the aliquots of solution B with or without collagen were allowed to crystallize and were lyophilized.
(Du, p. 519, par. 4), whereby calcium phosphate in Du’s calcium phosphate/collagen composites are encompassed by:
“calcium containing compounds” of claims 6 and 17,
“calcium phosphate compound” claims 2 and 13,
at least a “mineral/ceramic” that is at least “synthetically derived” of claims 4, 6 and 15 and 17, and
a “bioactive agent” of claims 2, 4, 9, 13, 15 and 20.
In light of these teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to take Li’s “[f]lat self-curling permeable sheet membrane,” “further comprising a bioactive agent” (Li, claims 1-4 and 6), and to have incorporated calcium phosphate per Du (Du, asbtract). One would have been motivated to do so with a reasonable expectation of success since both Li and Du are concerned with similar problems in the art, namely the manufacture of materials suitable for implants composed of collagen sheet materials. Li, abstract; Du, p. 519, par. 4. Further, it is well within the skill of the ordinary artisan to select a suitable bioactive material. (Li, par. [0007]. Doing so amounts to no more than combining prior art elements according to known methods to yield predictable results, namely the incorporation of a bioactive material that incorporates the advantage of a composite that “show[s] biodegradability” “partly through a multinucleated giant cell mediated process” for supporting “bone-derived cells deposit[ing] mineralizing collagenous matrix on the composite” (Du, abstract).
Thus, the prior art renders claims 2, 4, 6, 13, 15 and 17 obvious.
Regarding claims 9 and 20, it is noted that MPEP § 2144.05 (I), states, “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d, 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).” In this regard, Du teaches “calcium phosphate/collagen composites,” wherein “[t]he mineral contributed up to 60–70% of the weight of the final composites” (Du, asbtract), i.e., a ratio of collagen to bioactive agent of up to 40:60 to 30:70.
Thus, the prior art renders claims 9 and 20 obvious.
Claims 3, 6-7, 14 and 17-18 are rejected under 35 U.S.C. § 103 as being unpatentable over LI (US 2013/0004559 A1, Publ. Jan. 3, 2013; on 11/09/2023 IDS; hereinafter, “Li”), in view of DU (Du.C., et al., Formation of calcium phosphate/collagen composites through mineralization of collagen matrix, J. Biomed. Mater. Res., 50 (Apr. 07, 2000) pp. 518-527; hereinafter, “Du”), as applied to claims 1-2, 4, 6, 8-13, 15, 17 and 19-20, above, and further in view of GALLINETTI (Gallinetti, S., et al., Development and Characterization of Biphasic Hydroxyapatite/β-TCP Cements, J. Am. Cer. Soc., 97 (2014) pp. 1065-1073; hereinafter, “Gallinetti”).
The teachings of Li and Du, as set forth above, are hereby incorporated. However, the references DO NOT EXPRESSLY TEACH a hydroxyapatite/β-TCP material per the requirements of claims 3, 6-7, 14 and 17-18:
3. ([…]) The sheet membrane of claim 2, wherein the calcium phosphate compound is selected from the group consisting of tricalcium phosphate, tetra calcium phosphate, and hydroxyapatite.
[…]
6. ([…]) The sheet membrane of claim 4, wherein the synthetically derived mineral/ceramic is selected from the group consisting of synthetically derived β-TCP (tricalcium phosphate), hydroxyapatite, biphasic mineral and calcium containing compounds.
7. ([…]) The sheet membrane of claim 6, wherein the biphasic mineral is hydroxyapatite/β-TCP.
[…]
14. ([…]) The sheet membrane of claim 11, wherein the calcium phosphate compound is selected from the group consisting of tricalcium phosphate, tetra calcium phosphate, and hydroxyapatite.
[…]
17. ([…]) The sheet membrane of claim 15, wherein the synthetically derived mineral/ceramic is selected from the group consisting of synthetically derived β-TCP (tricalcium phosphate), hydroxyapatite, biphasic mineral and calcium containing compounds.
18. ([…]) The sheet membrane of claim 17, wherein the biphasic mineral is Hydroxyapatite/β-TCP.
Based on the state of the art, an artisan of ordinary skill would have found this feature obvious.
Gallinetti, for instance, is directed to:
Development and Characterization of Biphasic Hydroxyapatite/β-TCP Cements
Biphasic calcium phosphate bioceramics composed of hydroxyapatite (HA) and b-tricalcium phosphate (β -TCP) have relevant properties as synthetic bone grafts, such as tunable resorption, bioactivity, and intrinsic osteoinduction. However, they have some limitations associated to their condition of high-temperature ceramics. In this work self-setting Biphasic Calcium Phosphate Cements (BCPCs) with different HA/β-TCP ratios were obtained from self-setting a-TCP/β-TCP pastes. The strategy used allowed synthesizing BCPCs with modulated composition, compressive strength, and specific surface area. Due to its higher solubility, α-TCP was fully hydrolyzed to a calcium-deficient HA (CDHA), whereas β -TCP remained unreacted and completely embedded in the CDHA matrix. Increasing amounts of the non-reacting β-TCP phase resulted in a linear decrease of the compressive strength, in association to the decreasing amount of precipitated HA crystals, which are responsible for the mechanical consolidation of apatitic cements. Ca2+ release and degradation in acidic medium was similar in all the BCPCs within the timeframe studied, although differences might be expected in longer term studies once β -TCP, the more soluble phase was exposed to the surrounding media.
(Gallinetti, title & abstract), wherein calcium phosphate bioceramics composed of hydroxyapatite (HA) and b-tricalcium phosphate (β -TCP) are are encompassed by:
“hydroxyapatite/β-TCP” of claims 7 and 18,
“β-TCP (tricalcium phosphate), hydroxyapatite” of claims 6 and 17,
a “biphasic mineral” of claims 6-7 and 17-18,
“calcium phosphate compound” claims 2 and 13,
“tricalcium phosphate” and “hydroxyapatite” of claims 3 and 14,
at least a “mineral/ceramic” that is at least “synthetically derived” of claims 4, 6 and 15 and 17, and
a “bioactive agent” of claims 2, 4, 9, 13, 15 and 20.
In light of these teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to take Li’s “[f]lat self-curling permeable sheet membrane,” “further comprising a bioactive agent” (Li, claims 1-4 and 6), and to have incorporated “bioceramics composed of hydroxyapatite (HA) and b-tricalcium phosphate (β -TCP)” per Gallinetti (Gallinetti, abstract). One would have been motivated to do so with a reasonable expectation of success since both Li and Gallinetti are concerned with similar problems in the art, namely the manufacture of materials suitable for applications including bone treating implants in dental surgery, orthopedic/spine surgery (Li, par. [0045]-[0049]) “bone remodeling” (Gallinetti, p. 1071, par. 7). Further, it is well within the skill of the ordinary artisan to select a suitable bioactive material. Li, claim 6. Doing so amounts to no more than combining prior art elements according to known methods to yield predictable results, namely the incorporation of “[b]iphasic calcium phosphate bioceramics composed of hydroxyapatite (HA) and b-tricalcium phosphate (β -TCP)” in order to obtain the advantage of “relevant properties as synthetic bone grafts, such as tunable resorption, bioactivity, and intrinsic osteoinduction” (Gallinetti, abstract).
Thus, the prior art renders claims 3, 6-7, 14 and 17-18 obvious.
Claims 5 and 16 are rejected under 35 U.S.C. § 103 as being unpatentable over LI (US 2013/0004559 A1, Publ. Jan. 3, 2013; on 11/09/2023 IDS; hereinafter, “Li”), in view of DU (Du.C., et al., Formation of calcium phosphate/collagen composites through mineralization of collagen matrix, J. Biomed. Mater. Res., 50 (Apr. 07, 2000) pp. 518-527; hereinafter, “Du”), as applied to claims 1-2, 4, 6, 8-13, 15, 17 and 19-20, above, and further in view of SNYDERS (US 5,425,769, Issued Jun. 20, 1995; on 11/09/2023 IDS; hereinafter, “Snyders”).
The teachings of Li and Du, as set forth above, are hereby incorporated. However, the references DO NOT EXPRESSLY TEACH a “mineral/ceramic from natural sources” such as “bone material” per the requirements of claims 5 and 16:
5. ([…]) The sheet membrane of claim 4, wherein the mineral/ceramic from natural sources is selected from the group consisting of an organic bone material, natural carbonate apatite and a mixture containing carbonate apatite and one or more calcium-containing compounds.
[…]
16. ([…]) The sheet membrane of claim 15, wherein the mineral/ceramic from natural sources is selected from the group consisting of an organic bone material, natural carbonate apatite and a mixture containing carbonate apatite and one or more calcium-containing compounds.
Which is well within the purview of the ordinarily skilled artisan.
Snyders, for instance, is directed to:
COMPOSITION OF MATERIAL FOR OSSEOUS REPAIR
ABSTRACT
An artificial bone substitute composition consisting of fibrous collagen in a calcium sulfate matrix for incorporation in the human body for ultimate replacement by the body in a metabolic turnover and which can be rendered porous by a foaming agent. Such a composition is adaptable for osseous repair by adjusting the collagen and the calcium sulfate in varying ratios to suit particular applications and including admixtures of growth factors. The composition is prepared in a method of formulating a resorbable material by immobilizing a collagen material having mechanical strength characteristics within a calcium sulfate material and subjecting the composition to a hydration reaction which passes through a fluid state to a moldable state and to a solid.
Snyders, title & abstract. In this regard, Snyders discusses the prior art for osseous repair including (autogenous bone grafting, involving the transplantation of bone from another part of a patient's skeleton to the treatment site), allogenic and alloplastic alternatives (e.g., allogenic (freeze-dried) bone and alloplastic ceramics such as calcium phosphates (hydroxylapatite, tricalcium phosphate), and incorporation of calcium phosphate granules into a binding matrix such as plaster of Paris or collagen:
2. Description of the Prior Art
At present, the most effective ameliorative treatment for osseous repair is autogenous bone grafting, involving the transplantation of bone from another part of a patient's skeleton to the treatment site. Although widely employed, this method has several disadvantages including limited tissue availability and donor site morbidity. Donor site problems in particular discourage wider use of autogenous bone material in elective procedures (e.g., cosmetic bone augmentation, dental implants, periodontal therapy) where the risks to often outweigh potential benefits.
To overcome such problems both allogenic and alloplastic alternatives have been employed. Allogenic (freeze-dried) bone has been utilized with some success, but is expensive and does not heal as well as autogenous bone. Alloplastic ceramics, most notably the calcium phosphates (hydroxylapatite, tricalcium phosphate), have been used quite extensively in bone repair. Employed in both porous and nonporous forms, hydroxylapatite is quite stable in vivo and for all practical purposes, does not resorb. Tricalcium phosphate, while less stable in vivo, still undergoes bioresorption at a very slow rate. While quite appropriate for certain applications (e.g., onlay contouring), this extreme biostability translates into poor working qualities and inhibition of desired bony replacement in other commonly encountered situations.
Attempts to enhance both working qualities and bony replacement in calcium phosphate implants are represented by incorporation of calcium phosphate granules into a binding matrix such as plaster of Paris or collagen. While these adaptations certainly increase workability and encourage bony ingrowth through partial resorption, the phosphate particles will continue to endure and become incorporated in, rather than be replaced by, new host bone. By nature, this introduces planes of weakness into the bony structure which, while acceptable in certain situations, is undesirable in others, and would be preferably avoided where neuromuscular control of bone resorption is not an overriding concern (i.e., onlay contouring). Additional disadvantages include inability of the malleable collagen matrix to attain a solid state in vivo and the resistance of solidifying plaster matrices to molding, as well as the inability of either to be affixed by screw plate attachments.
(Snyders col. 1, ln. 13-41), and further notes “collagen, impregnated with a bone-derived inductive factor”:
To this end, the literature has shown the ability of collagen, impregnated with a bone-derived inductive factor, to be transformed into a bony ossicle (complete with marrow cavity) when implanted in vivo, even in sites (such as muscle) where bone would not normally develop. In no case has this same protein been shown to promote bone formation in the absence of an appropriate scaffolding.
(Snyders col. 2, ln. 3-10). It is noted that “autogenous bone grafting, involving the transplantation of bone from another part of a patient's skeleton to the treatment site” (Snyders col. 1, ln. 15-17) is encompassed by “organic bone material” of claims 5 and 16, and a “mineral/ceramic from natural sources” of claims 4-5 and 15-16.
In light of these teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to incorporate “autogenous bone grafting” per Snyders (Snyders col. 1, ln. 15-17) in Li’s “[f]lat self-curling permeable sheet membrane,” “further comprising a bioactive agent” (Li, claims 1-4 and 6). One would have been motivated to do so with a reasonable expectation of success if one wished to manufacture of materials suitable for applications including bone treating implants in dental surgery, orthopedic/spine surgery (Li, par. [0045]-[0049]) as a composite of a calcium phosphate contaringing material with collagen (Du, abstract; Snyders col. 2, ln. 3-10). Further, Snyders teaches an overlapping set of “osseus repair” materials, thereby establishing (autogenous bone grafting, involving the transplantation of bone from another part of a patient's skeleton to the treatment site), allogenic and alloplastic alternatives (e.g., allogenic (freeze-dried) bone and alloplastic ceramics such as calcium phosphates (hydroxylapatite, tricalcium phosphate), and incorporation of calcium phosphate granules into a binding matrix such as plaster of Paris or collagen (Snyders col. 1, ln. 13-41), as functional equivalents. Regarding equivalents known for the same purpose, MPEP § 2144.06 (II) states: “An express suggestion to substitute one equivalent component or process for another is not necessary to render such substitution obvious. In re Fout, 675 F.2d 297, 213 USPQ 532 (CCPA 1982).” Further, it is well within the skill of the ordinary artisan to decide how to manufacture an “osseus repair” material based on availability of material, cost, and desired quantity.
Thus, the prior art renders claims 5 and 16 obvious.
Claim Rejections - Nonstatutory Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 1, 8, 10-11, 12 and 19 are rejected on the ground of nonstatutory double patenting over claims 1-4, 6 and 20 of US Patent 9,061,464 B2 to Li et al., hereinafter “‘464 Patent,” matured from copending Application No. 13/173,966.
Although the conflicting claims are not identical, they are not patentably distinct because the instant claims as well as the copending claims are drawn to a flat self-curling composite sheet membrane comprising a flat layer of collagen and a bioactive agent, wherein the flat layer self-curls into a predetermined shape upon absorption of an aqueous fluid.
Claim 1 is anticipated by claims 1-3 and 6 of the ‘464 Patent.
Claim 8 is anticipated by claim 4 of the ‘464 Patent.
Claim 10 is anticipated by claim 20 of the ‘464 Patent.
Claim 11 is anticipated by claims 1-3 and 6 of the ‘464 Patent.
Claim 12 is anticipated by claim 20 of the ‘464 Patent.
Claim 19 is anticipated by claim 4 of the ‘464 Patent.
Claims 2, 4, 6, 9, 13, 15, 17 and 20 are rejected on the ground of nonstatutory double patenting over claims 1-4, 6 and 20 of US Patent 9,061,464 B2 to Li et al., hereinafter “‘464 Patent,” matured from copending Application No. 13/173,966, as applied to claims 1, 8, 10-11, 12 and 19, above, and in view of the disclosure of DU (Du.C., et al., Formation of calcium phosphate/collagen composites through mineralization of collagen matrix, J. Biomed. Mater. Res., 50 (Apr. 07, 2000) pp. 518-527; hereinafter, “Du”).
Although the conflicting claims are not identical, they are not patentably distinct because the instant claims as well as the copending claims are drawn to a flat self-curling composite sheet membrane comprising a flat layer of collagen and a bioactive agent, wherein the flat layer self-curls into a predetermined shape upon absorption of an aqueous fluid. To the extent the ‘464 Patent DOES NOT TEACH the particular incorporation of calcium phosphate materials, or amounts thereof, per the requirements of claims 2, 4, 6, 9, 13, 15, 17 and 20, these requirements would be obvious per Du, for similar reasons, as discussed above.
Thus, the ‘464 Patent per Du render claims 2, 4, 6, 9, 13, 15, 17 and 20 obvious.
Claims 3, 6-7, 14 and 17-18 are rejected on the ground of nonstatutory double patenting over claims 1-4, 6 and 20 of US Patent 9,061,464 B2 to Li et al., hereinafter “‘464 Patent,” matured from copending Application No. 13/173,966, in view of the disclosure of DU (Du.C., et al., Formation of calcium phosphate/collagen composites through mineralization of collagen matrix, J. Biomed. Mater. Res., 50 (Apr. 07, 2000) pp. 518-527; hereinafter, “Du”), as applied to claims 2, 4, 6, 9, 13, 15, 17 and 20, above, and further in view of the disclosure of GALLINETTI (Gallinetti, S., et al., Development and Characterization of Biphasic Hydroxyapatite/β-TCP Cements, J. Am. Cer. Soc., 97 (2014) pp. 1065-1073; hereinafter, “Gallinetti”).
Although the conflicting claims are not identical, they are not patentably distinct because the instant claims as well as the copending claims are drawn to a flat self-curling composite sheet membrane comprising a flat layer of collagen and a bioactive agent, wherein the flat layer self-curls into a predetermined shape upon absorption of an aqueous fluid. To the extent the ‘464 Patent DOES NOT TEACH a hydroxyapatite/β-TCP material per the requirements of claims 3, 6-7, 14 and 17-18, these requirements would be obvious per Gallinetti, for similar reasons, as discussed above.
Thus, the ‘464 Patent per Gallinetti render claims 3, 6-7, 14 and 17-18 obvious.
Claims 5 and 16 are rejected on the ground of nonstatutory double patenting over claims 1-4, 6 and 20 of US Patent 9,061,464 B2 to Li et al., hereinafter “‘464 Patent,” matured from copending Application No. 13/173,966, in view of the disclosure of DU (Du.C., et al., Formation of calcium phosphate/collagen composites through mineralization of collagen matrix, J. Biomed. Mater. Res., 50 (Apr. 07, 2000) pp. 518-527; hereinafter, “Du”), as applied to claims 2, 4, 6, 9, 13, 15, 17 and 20, above, and further in view of the disclosure of SNYDERS (US 5,425,769, Issued Jun. 20, 1995; on 11/09/2023 IDS; hereinafter, “Snyders”).
Although the conflicting claims are not identical, they are not patentably distinct because the instant claims as well as the copending claims are drawn to a flat self-curling composite sheet membrane comprising a flat layer of collagen and a bioactive agent, wherein the flat layer self-curls into a predetermined shape upon absorption of an aqueous fluid. To the extent the ‘464 Patent DOES NOT TEACH a “mineral/ceramic from natural sources” such as “bone material” per the requirements of claims 5 and 16, these requirements would be obvious per Snyders, for similar reasons, as discussed above.
Thus, the ‘464 Patent per Snyders render claims 5 and 16 obvious.
Conclusion
Claims 1-20 are rejected. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DOMINIC LAZARO whose telephone number is (571)272-2845. The examiner can normally be reached on Monday through Friday, 8:30am to 5:00pm EST; alternating Fridays out.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, BETHANY BARHAM can be reached on (571)272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DOMINIC LAZARO/Primary Examiner, Art Unit 1611