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 .
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claim 53 is objected to because of the following informalities:
-Claim 53 recites “according to claim 35” in line 2. Examiner recommends amending to –according to claim 35, into—
Appropriate correction is required.
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 34-53 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
-Claim 34 recites “its surfaces” in line 2. It is unclear what “its” is referring to. Further clarification should be provided.
-Claim 35 recites “auxetic structure” in line 2. It is unclear whether this auxetic structure is the same or different from the auxetic structure originally referenced in claim 34, line 2.
-Claim 36 recites “moulded auxetic structure” in line 2. It is unclear whether this auxetic structure is the same of different from the auxetic structure originally referenced in claim 34, line 2.
-Claim 37 recites “a mesh or filaments comprising a thermoplastic material” in lines 1-2 and 2-3. It is unclear whether the thermoplastic material is required if the structure comprises a mesh. Further clarification should be provided.
-Claim 37 recites “a thermoplastic material” in lines 2-3. It is unclear whether this is the same or different from the thermoplastic material originally referenced in claim 37, line 2.
-Claim 38 recites “the thickness” in line 1. There is insufficient antecedent basis for this limitation in the claim.
-Claim 42 recites “cellulosic material” in line 3. It is unclear whether this is the same or different from the cellulosic material originally referenced in claim 42, line 2.
-Claim 44 recites “nanocellulose” in line 2. It is unclear whether this is the same or different from the cellulose recited in claim 34, line 1.
-Claim 45 recites “the nanocellulose” in line 1. There is insufficient antecedent basis for this limitation in the claim.
-Claim 45 recites “cellulose” in line 2. It is unclear whether this is the same or different from the cellulose originally referenced in claim 34, line 1.
-Claim 45 recites “the form” in line 2. There is insufficient antecedent basis for this limitation in the claim.
-Claim 49 recites “consisting entirely of…cellulose” in lines 1-2. It is unclear from this claim how the structure could consist entirely of the nanostructured or micro structured cellulose when the previous independent claims contained reference to other components of the structure specifically, “an auxetic structure.”
-Claim 50 recites “A support structure…mammal” in lines 1-2. It is unclear whether this claim depends on independent claim 34 since it does not contain reference to the limitations introduced in claim 34. Specifically, “structure” aside from a support structure is not required per the claim limitations and therefore, renders the claim indefinite.
-Claim 51 recites “the structure” in line 1. It is unclear whether this is referencing the “a structure” originally introduced in claim 34, line 1, or “a support structure” originally introduced in claim 50, line 1.
-Claim 52 recites “the structure” in line 1. It is unclear whether this is referencing the “a structure” originally introduced in claim 34, line 1, or “a support structure” originally introduced in claim 50, line 1.
-Claim 53 recites “the mammal” in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
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:
Claim(s) 34, 35, 37, 41, 42, 43, 46, 49, 50, 51, 52, 53 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pattinson (U.S. 10696034).
Regarding Claim 34, Pattinson teaches a structure comprising nanostructured or microstructured cellulose on at least one of its surfaces [Col 13, line 3]—reference to using cellulose acetate and [Col 5, lines 61]—reference to the filament being in the order of microns which fulfills the microstructure limitation, wherein the structure comprises an auxetic structure having a negative Poisson's ratio [Col 27, line 55]-discusses using auxetic mesh materials for the purpose of directing blood flow.
Regarding Claim 35, Pattinson teaches wherein the structure comprises a mesh-like, knitted, or woven auxetic structure [Col 5, lines 61-63].
Regarding Claim 37, Pattinson teaches wherein the structure comprises a mesh or filaments comprising a thermoplastic material, [Col 4, lines 47-50]—reference to thermoplastic polymer, the mesh or filaments comprising a thermoplastic material at least partially coated with a coating of the nanostructured or microstructured cellulose. [Abstract; “(1) printing using a polymer (e.g., cellulose acetate) dissolved in a solvent (e.g., acetone); (2) selectively bonding portions of a deposited filament onto one or more surfaces and/or one or more previously deposited filaments; (3) using particular toolpaths to create a fabric or similar material by creating a woven pattern; and (4) printing across multiple layers even when previous layers are not complete.”]
Regarding Claim 41, Pattinson discloses “the structure comprises filaments or a mesh” set forth in claim 34 [Abstract; “deposited filaments”] and mesh [Col 5, lines 61-63].
Pattinson teaches that filaments or mesh making up the structure comprise cellulosic material, but is silent as to the method of spinning. The claimed phrase “obtained by a spinning process” is being treated as a product by process limitation; that is, that the structure is made by a spinning process. As set forth in MPEP 2113, product-by-process claims are NOT limited to the manipulations of the recited steps, only to the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 U.S.C. 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. See MPEP 2113.
Thus, even though Pattinson is silent as to the process used to make the structure, filaments or mesh, it appears that the product in Pattinson would be the same or similar as that claimed; especially since both applicant’s product and the prior art product is made of a structure containing cellulosic filaments and mesh.
Regarding Claim 42, Pattinson discloses “the structure comprises filaments or a mesh” set forth in claim 34 [Abstract; “deposited filaments”] and mesh [Col 5, lines 61-63].
Pattinson teaches that filaments or mesh making up the structure comprise cellulosic material, but is silent as to the method of a printing process from a gel or a suspension comprising cellulosic material. The claimed phrase “from a cellulosic material by a printing process from a gel or a suspension comprising cellulosic material” is being treated as a product by process limitation; that is, that the structure is made by a printing process or suspension. As set forth in MPEP 2113, product-by-process claims are NOT limited to the manipulations of the recited steps, only to the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 U.S.C. 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. See MPEP 2113.
Thus, even though Pattinson is silent as to the process used to make the structure, filaments or mesh, it appears that the product in Pattinson would be the same or similar as that claimed; especially since both applicant’s product and the prior art product is made of a structure containing cellulosic filaments and mesh.
Regarding Claim 43, Pattinson teaches wherein the structure exhibits lateral expansion when subjected to tension[Col 4, lines 39-42]—where in-plane tension is interpreted to be tensioning that causes lateral expansion.
Regarding Claim 46, Pattinson teaches wherein the structure comprises openings that are configured to expand under load [Col 4, lines 39-42]—load is broadly interpreted to mean any force applied to the structure including pulling, tensions, etc.
Regarding Claim 49, Pattinson teaches the structure consisting entirely of the nanostructured or microstructured cellulose [Col 19, lines 57-61]—in which the description includes reference to the filaments forming a continuous length along the object or part.
Regarding Claim 50, Pattinson teaches wherein the support structure is configured to support a tissue or an organ of a mammal [Col 26, lines 32-34; “Printing onto a 3D template can also be enabled so that the fabric conformably matches a desired surface (e.g., a 3D printed model of a patient's organ).”] and [Col 1, lines 59-62]—discusses design considerations for variations in human tissue.
Regarding Claim 51, Pattinson teaches wherein the structure is a pelvic organ prolapse mesh, a urinary incontinence sling or tape for a human, a breast reconstruction support structure, a hernia mesh, or a fecal incontinence support structure [Col 27, lines 19-22; “Such customization is can be important for complex meshes used in operations such as repairing pelvic organ prolapse or stress urinary incontinence where complication rates are currently very high.”] and [Col 27, lines 22-27]—which discusses adaptations made to the mesh to maintain certain portions of the device in the aforementioned applications.
Regarding Claim 52, Pattinson teaches wherein the structure is a support mesh, a support sling, or a support tape [Col 27, lines 46-51]—includes mention of an invention including a mesh medical implant.
Regarding Claim 53, Pattinson teaches A method of treating a mammal, [Col 1, lines 59-62]—discusses design considerations for variations in human tissue.
comprising implanting a structure according to claim 35, into a body of the mammal to support a tissue or an organ of the mammal [Col 27, lines 19-22; “Such customization is can be important for complex meshes used in operations such as repairing pelvic organ prolapse or stress urinary incontinence where complication rates are currently very high.”] and [Col 27, lines 46-51]—mentions an invention including a mesh medical implant.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
Claim(s) 36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pattinson (U.S. 10696034) in view of Yang (U.S. 20180117219).
Regarding Claim 36, Pattison is silent on wherein the structure comprises a moulded auxetic structure [0046]—description containing reference to a 3D micro jetting free molding technique, having openings extending through the structure. Yang teaches wherein the structure comprises a moulded auxetic structure having openings extending through the structure [0089]—reference to Fig. 3a and holes across the face of the cylinder.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to create the implant using a mold process as taught by Yang to obtain an auxetic structure with openings extending through the structure as suggested by Pattinson because Pattinson discusses the advantages of using 3D printing techniques over reliance on existing molds [Col 2, lines 49-53] with Yang because Yang teaches the use over molding techniques to enhance precision and resolution during processing methods [0046].
Claim(s) 38, 39, 40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pattinson (U.S. 10696034) in view of Ouderkirk (U.S. 11448798).
Regarding Claim 38, Pattinson is silent on wherein the thickness of the coating is at least 10 nm. Ouderkirk teaches wherein the thickness of the coating is at least 10 nm [Col 29, lines 52-55]—references the thickness of the polymer layer (interpreted to be the cellulose layer) being on the same scale as the voids. [Col 29, lines 57; “between
approximately 10 nm and approximately 1000 nm”]
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a thickness greater than 10nm as taught by Yang to incorporate when layering the nano/microstructured cellulose layers as suggested by Pattinson because Pattinson discloses adjusting these thicknesses to vary mechanical responses to outside forces [Col 4, lines 30-35]] with Ouderkirk because Ouderkirk teaches the considerations when selecting thickness and the effects that thickness has on exerting pressure and the correlation of this property to density [Col 30, lines 8-19].
Regarding Claim 39, Pattinson is silent on wherein the thickness of the coating is in the range of 20 to 500 nm. Ouderkirk teaches wherein the thickness of the coating is in the range of 20 to 500 nm [Col 29, lines 57; “between
approximately 10 nm and approximately 100 nm”] and [Col 30, line 1; “approximately 500 nm].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a thickness greater than 10nm as taught by Yang to incorporate when layering the nano/microstructured cellulose layers as suggested by Pattinson because Pattinson discloses adjusting these thicknesses to vary mechanical responses to outside forces [Col 4, lines 30-35]] with Ouderkirk because Ouderkirk teaches the considerations when selecting thickness and the effects that thickness has on exerting pressure and the correlation of this property to density [Col 30, lines 8-19].
Regarding Claim 40, Pattinson is silent on wherein the thickness of the coating is in the range of 50 to 150 nm. Ouderkirk teaches wherein the thickness of the coating is in the range of 50 to 150 nm [Col 29, lines 60-64; “50 nm…approximately 150 nm”]
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a thickness greater than 10 nm as taught by Yang to incorporate when layering the nano/microstructured cellulose layers as suggested by Pattinson because Pattinson discloses adjusting these thicknesses to vary mechanical responses to outside forces [Col 4, lines 30-35]] with Ouderkirk because Ouderkirk teaches the considerations when selecting thickness and the effects that thickness has on exerting pressure and the correlation of this property to density [Col 30, lines 8-19].
Claim(s) 44 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pattinson (U.S. 10696034) in view of Tang (CN 106366615).
Regarding Claim 44, Pattinson is silent on wherein the structure comprises nanocellulose. Tang teaches wherein the structure comprises nanocellulose [0001].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use nanocellulose as taught by Tang to provide materials for extrusion based 3-D printing as suggested by Pattinson because Pattinson considering filament sizes including a diameter of at least 10 mm, or 100 µm [abstract] with Tang because Tang teaches the widespread use of nanocellulose in composite reinforcement materials [0004]
Claim(s) 45 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pattinson (U.S. 10696034) in view of Martinez-Duarte (U.S. 20190112191).
Regarding Claim 45, Pattinson is silent on wherein the nanocellulose comprises cellulose produced by bacteria in the form of nanofibrils or wood-based cellulose which has been disintegrated to nanostructured cellulose. Martinez-Duarte teaches wherein the nanocellulose comprises cellulose produced by bacteria in the form of nanofibrils or wood-based cellulose which has been disintegrated to nanostructured cellulose [0044]—includes reference to the use of bacterial cellulose and the nanofibril structure of bacterial cellulose.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use cellulose produced by bacteria as taught by Tang to creating the nanostructured cellulose as suggested by Pattinson because Pattinson discusses the use of a bacterial cellulose preferred material [Col 16, lines 54-58] with Martinez-Duarte because Martinez-Duarte teaches the use of a dispersion of bacterial cellulose to effect entangling of nanofibrils [0040].
Claim(s) 47, 48 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pattinson (U.S. 10696034) in view of Li (WO 2019213134).
Regarding Claim 47, Pattinson is silent on wherein the structure has a Young's Modulus of at least 700 MPa in a wet condition. Li teaches wherein the structure has a Young's Modulus of at least 700 MPa in a wet condition [0080]—Young’s modulus is about 1460 MPa, in which the components of the mixture include liquids at room temperature.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to promote structural characteristics of the structure as taught by Li to incorporate into auxetic cellulose based material design as suggested by Pattinson because Pattinson specific stiffness, strength and flexibility of the described materials [Col 17, lines 25-30] with Li because Li teaches rendering a high chain stiffness during reactions to form the structure [Abstract].
Regarding Claim 48, Pattinson is silent on wherein the structure has tensile strength of at least 1.5 MPa in a wet condition. Li teaches wherein the structure has tensile strength of at least 1.5 MPa in a wet condition [0080]—Tensile strength is 62 MPa, in which the components of the mixture include liquids at room temperature.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to promote structural characteristics of the structure as taught by Li to incorporate into auxetic cellulose based material design as suggested by Pattinson because Pattinson using pure cellulose with high tensile strength specifically for hernia repair [Col 17, lines 38-40] with Li because Li teaches the disadvantage of using conventional materials with tensile strength in tens of MPa as not having healable properties [0004].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
-Kim (U.S. 20200223099)—includes reference to an elastomeric matrix including auxetic properties.
-Frigstad (WO 2012116182)—discloses an auxetic structure with cellulose materials
-Topolkaraev (U.S. 20160108194)-includes nanoporous structure
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/B.N.K./Examiner, Art Unit 3791
/CHRISTINE H MATTHEWS/Primary Examiner, Art Unit 3791