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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Rejections - 35 USC § 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 1-5 and 13-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhao et al. (CN 107050529 A).
Regarding claim 1, Zhao discloses a biological sleeve (figs. 10 and 11 illustrate an biological bag/sleeve; see ¶ 0081-0082), wherein the biological sleeve is formed of a sterilized (¶ 0012 and ¶ 0091) and decellularized (see ¶ 0085) extracellular matrix material (see ¶ 0023), and has an integrally molded pocket structure (see ¶ 0031 and pocket/bag opening 2 in figs. 10 and 11); and the pocket structure has an accommodation cavity for accommodating an implantable medical device (¶ 0078 discloses a bag/pocket structure 1 for accommodating an implantable contraceptive device), and an opening that communicates the accommodation cavity with the outside (see element 2 in figs. 10 and 11).
Regarding claim 2, Zhao discloses the invention as claimed as discussed above with respect to claim 1. Zhao further discloses that the accommodation cavity is enclosed by a first surface body and a second surface body that are opposite to each other (¶ 0088; also see figs. 10 and 11); wherein the portion where the first surface body and the second surface body are connected forms a transitional connecting portion of the biological sleeve (¶ 0088 discloses that shaping the bag/pocket structure by creating a fold as the long bottom edge, i.e. the transitional portion connecting a first and second surface body).
Regarding claim 3, Zhao discloses the invention as claimed as discussed above with respect to claim 2. Zhao further discloses that at least one microhole is provided on the first surface body and/or the second surface body (¶ 0022; figs. 10 and 11 illustrate a bag/pouch/pocket like structure with perforations/microholes).
Regarding claim 4, Zhao discloses the invention as claimed as discussed above with respect to claim 1. Zhao further discloses that the sterilized and decellularized extracellular matrix material is obtained by taking small intestinal submucosa tissue and subjecting it to virus inactivation treatment and decellularization treatment (¶ 0024 discloses preparation methods which include taking a small intestine submucosal tissue and performing steps of viral inactivation and decellularization).
Regarding claim 5, Zhao discloses the invention as claimed as discussed above with respect to claim 4. Zhao further discloses a step is further included between the step of the virus inactivation treatment and the step of the decellularization treatment, the step being a step of cleaning the small intestinal submucosa tissue until detected conductivity of the small intestinal submucosa tissue is reduced to 10 μS/cm or less (¶ 0024 discloses a washing/cleaning step between the virus inactivation and decellularization step and ¶ 0027 further discloses that the washing/cleaning step is stopped when the conductivity is detected to be below 10 μS/cm).
Regarding claim 13, Zhao discloses the invention as claimed as discussed above with respect to claim 3. Zhao further discloses that the microhole has a diameter of 1 to 3 mm (¶ 0022 discloses that the perforations/microholes may have a diameter between 0.5 and 3 mm).
Regarding claim 14, Zhao discloses the invention as claimed as discussed above with respect to claim 3. Zhao further discloses that the spacing between the microholes is 10 to 15 mm (¶ 0022 discloses that the spacing between the perforations/microholes may be 1 cm/1 mm, falling in the claimed range of the present application).
Regarding claim 15, Zhao discloses the invention as claimed as discussed above with respect to claim 4. Zhao further discloses that a step of the virus inactivation treatment comprises: immersing the small intestinal submucosa tissue in a virus inactivation solution containing (0.1 to 5)% (v/v) peroxyacetic acid and (5 to 40)% (v/v) ethanol, and treating for 2 to 4 hours at a temperature of 10°C to 40°C (see ¶ 0026).
Regarding claim 16, Zhao discloses the invention as claimed as discussed above with respect to claim 4. Zhao further discloses that a step of the decellularization treatment comprises: immersing the small intestinal submucosa tissue in a decellularization solution containing 0.1 to 2 wt% of trypsin and 0.01 to 0.3 wt% of EDTA (¶ 0028 discloses a decellularization solution containing a trypsin concentration of 0.01-0.2% and an EDTA concentration of 0.1-1 mmol/L (equivalent to 0.0029 to 0.029 wt%) both disclosed concentrations of trypsin and EDTA falling in the claimed range of the present application), and treating for 10 to 60 min at a temperature of 10°C to 40°C under ultrasonic conditions with ultrasonic power of 5000 W or greater (¶ 0028 further discloses that the treatment may last between 5-40 minutes at a temperature of 20-35 C and wherein the ultrasonic power is 5000 W or higher, all ranges falling in the claimed ranges of the present application).
Regarding claim 17, Zhao discloses the invention as claimed as discussed above with respect to claim 5. Zhao further discloses that a step is further included after the step of the decellularization treatment, the step being a step of cleaning the small intestinal submucosa tissue until the detected conductivity of the small intestinal submucosa tissue is reduced to 1 μS/cm or less (¶ 0027 discloses that the washing/cleaning step is stopped when the conductivity is detected to be below 10 μS/cm a range that includes 1 μS/cm or less as claimed in the present application).
Claims 1-2 and 10-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Matheny et al. (CN 104661701 A).
Regarding claim 1, Matheny discloses a biological sleeve (sleeve/encapsulating layer 14), wherein the biological sleeve is formed of a sterilized (it is known in the art that a medical implant and any additional components entering the body must be sterilized before implantation) and decellularized extracellular matrix material (see ¶ 0019 and ¶ 0056 for decellularized ECM), and has an integrally molded pocket structure (see figs. 6); and the pocket structure has an accommodation cavity for accommodating an implantable medical device (¶ 0136 discloses that the encapsulated/pocket/bag/pouch structure is configured to accommodate a medical device), and an opening that communicates the accommodation cavity with the outside (¶ 0136 discloses that the cavity has a certain size to receive and retain the medical device and figs. 6 and 7 illustrate an opening that communicates the cavity with the outside, e.g. for lead routing and connection to the medical device).
Regarding claim 2, Matheny discloses the invention as claimed as discussed with respect to claim 1. Matheny further discloses that the accommodation cavity is enclosed by a first surface body and a second surface body that are opposite to each other (see figs. 6-7 which illustrate an encapsulating structure, pocket, sleeve, or pouch in which a cavity, that receives a medical implant, is enclosed by an upper portion and a lower portion oppositely facing each other); wherein the portion where the first surface body and the second surface body are connected forms a transitional connecting portion of the biological sleeve (see figs. 6-7 which illustrate an encapsulating structure, pocket, sleeve, or pouch with rounded transition connection portions of the upper portion and lower portion of the sleeve).
Regarding claim 10, Matheny discloses an implantable medical apparatus, wherein the implantable medical apparatus comprises: a biological sleeve according claim 1 (see claim 1 above); and an implantable medical device that is at least partially placed in an accommodation cavity of the biological sleeve (see claim 1; and figs. 6-7); optionally, the implantable medical device is selected from the group consisting of devices for diagnosis, monitoring and/or treatment of cardiovascular diseases (¶ 0003 discloses the implantable medical device is a cardiovascular implant); optionally, the implantable medical device is any one selected from the group consisting of: a cardiac pacemaker, an implantable cardioverter defibrillator, a cardiac resynchronization therapy pacemaker, an implantable defibrillator, an insertable cardiac monitor, and an implantable cardiovascular monitor (¶ 0021 discloses that the medical device may include a pacemaker, defibrillator, physiological sensors (i.e. monitors)).
Regarding claim 11, Matheny discloses a method for accommodating an implantable medical device (¶ 0127 and ¶ 0136 disclose methods of accommodating an implantable device), wherein the method comprises using a biological sleeve according to claim 1 (see claim 1 above); optionally, the implantable medical device is selected from the group consisting of devices for diagnosis, monitoring and/or treatment of cardiovascular diseases (¶ 0003 discloses the implantable medical device is a cardiovascular implant); optionally, the implantable medical device is any one selected from the group consisting of: a cardiac pacemaker, an implantable cardioverter defibrillator, a cardiac resynchronization therapy pacemaker, an implantable defibrillator, an insertable cardiac monitor, and an implantable cardiovascular monitor (¶ 0021 discloses that the medical device may include a pacemaker, defibrillator, physiological sensors (i.e. monitors)).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 6-9 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Zhao et al. (CN 107050529 A), as applied to claim 1 above, in view of Novak (WO 2018017611 A1), in further view of Matheny (US 20130023721 A1), and in further view of Hiles et al. (US 6187039 B1).
Regarding claim 6, Zhao discloses a method for preparing a biological sleeve according to claim 1 (see claim 1 above), wherein the preparation method comprises the following steps: a preparation step of a biofilm layer: preparing a sterilized (¶ 0012 and ¶ 0091) and decellularized small intestinal submucosa material as a biofilm layer for preparing the biological sleeve (see ¶ 0020); a coating step of the biofilm layer: coating the biofilm layers on the surface of a plate-shaped mold, so that the surface is coated with at least two layers of the biofilm layers, respectively (¶ 0030 discloses that one or more biofilm layers/layers of small intestinal submucosal matrix material are laid flat on a plate mold). Zhao also discloses a freeze-drying step: subjecting the biofilm layer coated on the mold to a freeze-drying treatment in a non-compression environment (see ¶ 0087 which discloses a vacuum freeze-drying process, i.e. a low pressure/non-compression environment).
Zhao fails to disclose coating the biofilm layers on the surfaces of specifically both sides of a plate-shaped mold so that both sides are coated and that any one layer of the biofilm layers comprises a coating film layer coated on a partial area of the surface of one side, and a freeze-drying step specifically used to integrate the at least two layers of the biofilm layers; wherein the biofilm layers coating two surfaces form a first surface body and a second surface body respectively, the biofilm layer connecting the first surface body and the second surface body forms a transitional connecting portion, and the side of the biofilm layer that does not coat the mold forms an opening, thereby obtaining a biological sleeve integrally molded by the first surface body, the second surface body, and the transitional connecting portion.
Novak also discloses a method for preparing a biological sleeve (pg. 16 lines 17-18 disclose a method of preparing a biological sleeve/pouch product). Novak teaches coating the biofilm layers on the surfaces of both sides of a plate-shaped mold so that both sides are coated and that any one layer of the biofilm layers comprises a coating film layer coated on a partial area of the surface of one side (fig. 8a illustrates placing/coating both sides of a sheet/plate structure which is used to prevent the layers on either side from joining together at a center portion and thereby allowing the formation of a cavity which after drying can be removed, i.e. has a mold-like sheet/plate that facilitates the formation of a cavity for placement of a medical device, see pg. 16 lines 22-26) and a freeze-drying step specifically used to integrate the at least two layers of the biofilm layers (pg. 35 lines 9-11 discloses that a variety of dehydration-induced bonding methods can be used to fuse ECM or other sheet material together and lines 18-20 discloses freeze-drying/lyophilization); wherein the biofilm layers coating two surfaces form a first surface body and a second surface body respectively (fig. 8a illustrates a top/first portion/surface body and a bottom/second surface body that form the finished pouch/pocket seen in fig. 10a), the biofilm layer connecting the first surface body and the second surface body forms a transitional connecting portion, and the side of the biofilm layer that does not coat the mold forms an opening, thereby obtaining a biological sleeve integrally molded by the first surface body, the second surface body, and the transitional connecting portion (fig. 4b illustrates biofilm layer portions that connect a first surface body 12 to a second surface body 14 and a side of the biofilm layer that does not coat the mold forming an opening 36 as seen in fig. 6b which illustrates an integrally molded biological sleeve with a first body surface, second body surface, and transitional connecting portions; see fig. 4b and 6b below).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to coating the biofilm layers on the surfaces of specifically both sides of a plate-shaped mold so that both sides are coated and that any one layer of the biofilm layers comprises a coating film layer coated on a partial area of the surface of one side, and a freeze-drying step specifically used to integrate the at least two layers of the biofilm layers; wherein the biofilm layers coating two surfaces form a first surface body and a second surface body respectively, the biofilm layer connecting the first surface body and the second surface body forms a transitional connecting portion, and the side of the biofilm layer that does not coat the mold forms an opening, thereby obtaining a biological sleeve integrally molded by the first surface body, the second surface body, and the transitional connecting portion, as taught by Novak, as the modification merely involves a combination of known methods of folding, shaping, and manipulating biofilm layers or tissue that achieves predictable results of forming a pouch structure for the accommodation of an implantable medical device.
Zhao in view of Novak fails to disclose specifically alternately coating the biofilm layers and an extension film layer that extends continuously to the surface of the other side corresponding to the partial area.
Matheny also discloses a method for preparing a biological sleeve (¶ 0017 discloses creating encasement structures made of ECM/tissue)). Matheny teaches alternately coating the biofilm layers (fig. 3 illustrates one side of an object and subsequently coating the other side) and an extension film layer that extends continuously to the surface of the other side (fig. 3 illustrates the layer comprises an extension that extends continuously to the other side of an object).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the biofilm layer of Zhao to include alternately coating the biofilm layers and to include an that the biofilm layer comprises a extension film layer that extends continuously to the other side of an object or to the mold of Zhao as the modification merely involves a combination of known methods of folding, shaping, and manipulating biofilm layers or tissue that achieves predictable results of forming a pouch structure for the accommodation of an implantable medical device.
Zhao in view of Novak and Matheny fail to disclose that the biofilm layer is coated on a partial area of one side that that it continuously extends to the other side corresponding to the partial area. Hiles also discloses a method for preparing a biological sleeve (col. 1 lines 12-19 discloses producing tissue sleeves/constructs with biological tissue, e.g. submucosal tissue). Hiles teaches biofilm lengths that are able to continuously wrap until its entire length has been exhausted when coating an object. Additionally, Hiles teaches implantable submucosal tissue which is manufactured in any length, wall thickness, or diameter (abstract) to form a structure with an inner cavity by layering/wrapping biofilm or submucosal tissue around an object – specifically element 60 in fig. 5b which illustrates wrapping a piece of biofilm/submucosa tissue over itself. Furthermore, in the instance of a shorter length of biofilm, once exhausted a shorter length of biofilm may only cover certain portions of the object to be coated.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the biological sleeve of Zhao in view of Novak and Matheny to alter the length of a biofilm and include a biofilm layer of a length enough to wrap around itself or a biofilm layer that coats another biofilm layer, as taught by Hiles, in order to form a multi-layered tissue based device with sufficient strength and durability (col. 4 lines 3-6).
Regarding claim 7, Zhao in view of Novak, Matheny, and Hiles disclose the invention as claimed as discussed with respect to claim 6. Novak further discloses that the coating step of the biofilm layer comprises: taking the plate-shaped mold with both sides being a first face and a second face respectively (fig. 8a illustrates a sheet/plate mold with a first/top face and a second/bottom face), and reserving top areas of the first face and the second face that are opposite to each other as non- coated areas along the length direction of the mold (fig. 8a and 8b illustrate that the top edge of a sheet/plate mold 114 are not coated with the biofilm layers and fig. 6b illustrates an opening 36 as a result of this process), and the remaining areas as coated areas (fig. 8a illustrates that the remaining portions of the sheet/mold are covered coated and figs. 6a and 6b illustrate the resulting transitional portions in which the biofilm layers join together); coating a first biofilm layer on the coated area of the first face (Fig. 8a illustrates coating the first face with a first biofilm layer 110. Also see Hines et al. which teaches coating coated surfaces.), wherein the first biofilm layer forms the coating film layer of the first biofilm layer covering the coated area and the extension film layer of the first biofilm layer extending outward from the coated area (see Hines et al. which teaches coating coated areas and teaches extension portions of a film layer which continuously wrap around an object providing multiple layers of biofilm/submucosal layers); Matheny discloses bending the extension film layer in the direction of the second face (figs. 2-3 illustrate bending an extension portion of a biofilm layer to a second face of an object), so that the extension film layer covers the coated area of the second face (see Hines et al. which teaches coating coated surfaces as previously discussed); Matheny also discloses flattening the extension film layer on the second face to complete the coating step in the direction from the first face to the second face (see figs. 2-3); coating a second biofilm layer on the coated area of the second face (Fig. 8a also illustrates coating a second face with a second biofilm layer 112. Also see Hines et al. which teaches coating coated surfaces.), wherein the second biofilm layer forms the coating film layer of the second biofilm layer covering the coated area and the extension film layer of the second biofilm layer extending outward from the coated area (see Hines et al. which teaches coating coated areas and teaches extension portions of a film layer which continuously wrap around an object providing multiple layers of biofilm/submucosal layer); Matheny discloses bending the extension film layer of the second biofilm layer in the direction of the first face (figs. 2-3 illustrate bending an extension portion of a biofilm layer onto another face of an object, e.g. an opposite face), so that the extension film layer of the second biofilm layer covers the coated area of the first face (see Hines et al. which teaches coating coated areas with extension portions of a film layer which continuously wrap around an object providing multiple layers of biofilm/submucosal layer); and flattening the extension film layer on the first face to complete the coating step in the direction from the second face to the first face (Matheny illustrates flattening the extension film portion of a biofilm to coat an area in figs. 2-3).
Regarding claim 8, Zhao in view of Novak, Matheny, and Hiles disclose the invention as claimed as discussed with respect to claim 6. Zhao further discloses that the step of the freeze-drying treatment comprises: placing the biofilm in a vacuum freeze dryer for non-compressive freeze drying (¶ 0024 and ¶ 0087 disclose drying in a vacuum freeze-dryer, i.e. a low pressure/non-compression environment). Novak further teaches that the plate-shaped mold (114) coated with the biofilm layers (fig. 8a) is subject to freezing and dehydration/drying/lyophilization in order to bond the biofilm layers (pg. 35 lines 18-23).
Regarding claim 9, Zhao in view of Novak, Matheny, and Hiles disclose the invention as claimed as discussed with respect to claim 6. Zhao further discloses that the preparation method further comprises the following steps: a punching step: removing the biological sleeve from the mold, cutting to a desired size, and then punching a hole in the first surface body and/or the second surface body to form at least one microhole on the first surface body and/or the second surface body (¶ 0090 discloses that after drying the biofilm material is cut on a mold and then placed in a mechanical perforation machine to make holes, i.e. removed from mold and placed in perforation machine); preferably, punching a hole in the first surface body and/or the second surface body with microhole spacing of 10 to 15 mm and the diameter of 1 to 3 mm (¶ 0022 discloses that a surface of the biofilm pocket structure is perforated with holes comprising a spacing of 0.2cm-1cm and a diameter of 0.5mm-3mm); and a sterilization step: subjecting the biological sleeve to sterilization treatment with ethylene oxide after heat preservation treatment of the biological sleeve (¶ 0087 discloses step 6, the heat preservation/freeze drying step 6 and ¶ 0091 discloses step 9, the sterilization treatment with ethylene oxide), and then performing aeration to the ethylene oxide to obtain a sterilized biological sleeve (¶ 0091 discloses that the process is carried out in a ventilated analysis room, i.e. provides aeration, and ¶ 0106 discloses testing for excess amounts of residual ethylene oxide); preferably, the heat preservation treatment is carried out for 2 to 4 hours at a temperature of 20°C to 40°C and a humidity of 30% to 70%; preferably, the ethylene oxide is introduced at a concentration of 300 to 1000 mg/L, and the time of the sterilization treatment is 4 to 8 h; preferably, the step of performing aeration to the ethylene oxide is carried out in a ventilated aeration chamber with the temperature controlled at 10°C to 30°C for 14 to 28 days (see ¶ 0091).
Regarding claim 18, Zhao in view of Novak, Matheny, and Hiles disclose the invention as claimed as discussed with respect to claim 7. Novak discloses a first and second biofilm layer (fig. 8a; 110 and 112), Matheny teaches that the coating step in the direction from the first face to the second face, the extension film layer of the first biofilm layer completely coats the area of the second face; and/or in the coating step in the direction from the second face to the first face, the extension film layer of the second biofilm layer completely coats the area of the first face (see figs. 2-3 which illustrates coating a coating step in the direction from one face to another face to completely coat it), and Hiles teaches that the extension film of a biofilm layer specifically coats an already coated face (Hiles teaches using implantable submucosal tissue which is manufactured in any length, wall thickness, or diameter (abstract) to form a structure with an inner cavity by layering/wrapping biofilm or submucosal tissue around an object – specifically element 60 in fig. 5b which illustrates wrapping a piece of biofilm/submucosa tissue over itself).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of preparing a biological sleeve of Zhao in view of Novak and Matheny to include that that the extension film of a biofilm layer specifically coats an already coated face, as further taught by Hiles, in order to form a multi-layered tissue-based device with sufficient strength and durability (col. 4 lines 3-6).
Regarding claim 19, Zhao in view of Novak, Matheny, and Hiles disclose the invention as claimed as discussed with respect to claim 7. Novak discloses coating two faces of a mold/object with a biofilm, Matheny discloses a coating step in the direction from one face to another, and Hiles discloses that a coating step is repeated at least once (see element 14 in figs. 1-2 which illustrate wrapping a piece of biofilm/submucosa tissue over itself multiple times and forming numerous layers).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of preparing a biological sleeve of Zhao in view of Novak and Matheny to include that a coating step in the direction from the first face to the second face, and the coating step in the direction from the second face to the fist face are repeated at least once, as further taught by Hiles, in order to form a multi-layered tissue based device with sufficient strength and durability (col. 4 lines 3-6).
Regarding claim 20, Zhao in view of Novak and Matheny disclose the invention as claimed as discussed with respect to claim 8. Zhao further discloses that the conditions for the non- compression freeze drying comprise: pre-freezing to -45°C and holding for 1 to 2 h; then adjusting the temperature to -15°C and holding for 5 to 7 h; readjusting the temperature to 00C and holding for 2 h; and finally adjusting the temperature to 25°C and holding for 4 h (see ¶ 0087).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Matheny et al. (CN 104661701 A).
Regarding claim 12, Matheny discloses the invention as claimed as discussed with respect to claim 2. Matheny fails to disclose that the transitional connecting portion has a length specifically of 5 to 10 cm along the length direction of the biological sleeve, and the transitional connecting portion has a length specifically of 4 to 8 cm along the width direction of the biological sleeve.
Matheny discloses that a biological sleeve may include an ECM of various shapes and sizes to accommodate a medical device (see ¶ 0103, ¶ 0126, and ¶ 0136). However, Matheny does not explicitly disclose that the transitional connecting portion has a length specifically of 5 to 10 cm along the length direction of the biological sleeve, and the transitional connecting portion has a length specifically of 4 to 8 cm along the width direction of the biological sleeve, as required by the claim.
There is no evidence of record that establishes that changing the length of the transitional connecting portion or the length of the transitional connecting portion along the width direction of the biological sleeve would result in a difference in function of the Matheny et al. device. Further, a person having ordinary skill in the art, being faced with modifying the biological sleeve of Matheny et al., would have a reasonable expectation of success in making such a modification and it appears the device/sleeve would function as intended being given the claimed angles. Lastly, the applicant has not disclosed that the claimed range solves any stated problem, indicating that the angle “may be within the claimed range” and therefore appears to be no criticality placed on the range as claimed such that it produced an unexpected result.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the length of the transitional connecting portion to have a length between 5 to 10 cm and the length of the transitional connecting portion along the width direction of the biological sleeve to have a length between 4 to 8 cm as an obvious matter of design choice within the skill of the art.
Conclusion
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/A.G.B./Examiner, Art Unit 3774
/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774
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