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 § 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 2,7 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.
In claim 2, the recitation of "less than 20%" raises an issue of indefiniteness because one does not know the lower limit or if a change occurred as it could even encompass 0 according to the scope of less than 20% since it is an open-ended limitation.
In claim 7, it is not understood how the same biofilm is provided with two opposite sides serving as force-bearing portions, and wherein one of the two sides is a stationary edge, other one of the two sides is an opposite movable edge, and the tensile force is applied to the movable edge because it is not evident if the biofilm is provided with some movable element or is the force applying means intended to cause movement of an edge of the biofilm? Additionally what prevents the two sides being stationary from moving when a force is applied on the same biofilm that is not permitted to move?
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.
Claim(s) 1-6-8,11,12,14-20 are rejected under 35 U.S.C. 103 as being unpatentable over Maimon et al. (WO 2019/147585) in view of Peters et al. (NL 1008349) and Lafrance et al. (WO 03/007795). Maimon et al. disclose (paragraph 8) a preparation method for a biofilm material. Maimon et al. disclose (paragraph 9) providing a biofilm and then applying a tensile force in an X direction to the biofilm, paragraph 41. Maimon et al. also disclose (paragraphs 37,38) preforming (paragraph 60) treatment of the biofilm while it is under the tensile force to obtain the biofilm material. Maimon et al. also disclose (paragraphs 37,38) crosslinking treatment of the biofilm. However, Maimon et al. did not explicitly state crosslinking treatment of the biofilm while it is under the tensile force to obtain the biofilm material. Peters et al. teach (page 7 of translation) that biomaterial for leaflets can be crosslinked or under treatment while providing a force to the material. It would have been obvious to one of ordinary skill in the art to crosslink the biofilm while it is under the tensile force to obtain the biofilm material as taught by Peters et al. in manufacture of the leaflet of Maimon et al. such that the appropriate material properties are established in the leaflet. Maimon et al. also did not explicitly state the direction of tension, being the X direction aligns with a fiber direction of the biofilm. Lafrance et al. teach (Fig. 11B) applying a tensile force in an X direction to a biofilm 7000, wherein the X direction aligns with a fiber direction 6400 of the biofilm, see paragraph 112. It would have been obvious to one of ordinary skill in the art to crosslink the biofilm while it is under the tensile force to obtain the biofilm material as taught by Lafrance et al. in manufacture of the leaflet of Maimon et al. such that the appropriate material properties are established in the leaflet. Regarding claims 2,3, Maimon et al. disclose (paragraph 33) a thickness of the biofilm H1 and that thickness is evaluated after tensile force was applied to establish a second thickness H2 and then assessing a change rate to be (H2-H1)/H1 to be less than 20% and provide thickness value within the range of 2-15%. Regarding claim 4, it is noted that Maimon discloses (paragraph 43) at least one area to be treated in the biofilm which can be one axis or as best understood forces along that axis. Lafrance et al. teach (Fig. 11b) the at least one area to be treated has two opposite sides serving as force-bearing portions, such that is established the tensile force by two components that are applied in opposite directions to the two sides pulls on one axis. It would have been obvious to one of ordinary skill in the art to utilize two opposite pulling forces on one axis as taught by Lafrance et al. with the tissue preparation method of Maimon as modified with Peters in order to align fibers with that axis. With respect to claim 5, it can be seen that the area to be treated in the method of Maimon is provided with parallel sides, see Fig. 2. Additionally Lafrance et al. teach (Fig. 11B) the two sides are located at edge positions of the biofilm and parallel to each other. Regarding claim 6, it can be seen (Fig. 11B) that Lafrance et al. teach each of the two sides is fixed as a whole or provided with a plurality of fixing sites 6000 spaced apart along an extending direction thereof; and wherein the plurality of fixing sites on a same side are simultaneously applied with force, or separately applied with force based on change in the tensile force. With respect to claim 7, it is noted that Maimon discloses (paragraph 43) at least one area to be treated in the biofilm, the at least one area to be treated has two opposite sides serving as force-bearing portions, and wherein one of the two sides is a stationary edge, other one of the two sides is an opposite movable edge, and the tensile force is applied to the movable edge; or the two sides are both movable edges, and the tensile force comprises two components that are actively applied to each of the movable edges, see Fig 2. Additionally per the teaching of Lafrance (Fig. 11B) there are two movable sides and two stationary sides. This is an illustration of force in one direction as Maimon disclosed. With respect to claim 8, Lafrance et al. teach that each side is anchored by a connecting member, and the tensile force is applied to the connecting member, paragraphs 108,112. Regarding claim 11, Maimon discloses (paragraph 61) the step of applying the tensile force comprises applying the tensile force until it reaches a first predetermined value or until a deformation amount of the biofilm reaches a second predetermined value. With respect to claim 12, Maimon discloses (paragraph 61) the biofilm has an original first length along the fiber direction, the tensile force is applied to the biofilm until the biofilm reaches a second length along the fiber direction, with a stretching rate of 5% to 15%. Regarding claim 14, Maimon discloses (paragraph 61) tensioning forces are alternately repeated at least twice, with the tensile force applied increasing sequentially when repeating step S200, until the first predetermined value is reached after S200 is performed for a plurality of times. Regarding claim 15, Maimon discloses (paragraph 65) tensioning forces are alternately repeated at least twice, with the deformation amount of the biofilm increasing sequentially when repeating step S200, until the second predetermined value is reached after S200 is performed for a plurality of times. Regarding claim 16, Maimon discloses (paragraphs 54,55) the tensile force is maintained by fixing the biofilm to a supporting mechanism. With respect to claim 17, Lafrance teaches (Fig. 14) the support mechanism is a frame structure comprising a plurality of side frame strips 6000 that enclose a biofilm placement area, wherein at least one of the plurality of side frame strips is movably installed and adjustable in position relative to other side frame strips, or the plurality of side frame strips are fixedly connected, and each side frame strip is installed with the connecting member that is engageable with the biofilm, paragraph 108. Please note claims are given their broadest reasonable interpretation and thus the term “strips” has not been given any special definition or any requirements, i.e. a thickness, a material, a dimension. Thus, the pieces of material taught by Lafrance meet the scope of the claim and are “strips” of material. Regarding claim 18, see abstract of Maimon stating the method produces a biocompatible material. Regarding claim 19, Fig. 1 of Maimon shows a stent of a tubular meshed structure 12, with an interior of the tubular meshed structure defining a blood flow channel; and leaflets 16, mounted within the stent to control an open degree of the blood flow channel, wherein the leaflets are made of the biofilm material. Regarding claim 20, edges of each leaflets comprise: a fixed edge fixed to the stent, and a free edge configured to cooperate with free edges of adjacent leaflets in controlling the blood flow channel (see Fig. 1 of Maimon), and wherein an extending direction of each free edge aligns with a fiber direction (see paragraph 115 of Lafrance) of corresponding leaflet.
Claim(s) 1-12,14-16,18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Maimon et al. (WO 2019/147585) in view of Ogle et al. (2003/0229394). Maimon et al. disclose (paragraph 8) a preparation method for a biofilm material. Maimon et al. disclose (paragraph 9) providing a biofilm and then applying a tensile force in an X direction to the biofilm, paragraph 41. Maimon et al. also disclose (paragraphs 37,38) preforming (paragraph 60) treatment of the biofilm while it is under the tensile force to obtain the biofilm material. Maimon et al. also disclose (paragraphs 37,38) crosslinking treatment of the biofilm. However, Maimon et al. did not explicitly state crosslinking treatment of the biofilm while it is under the tensile force to obtain the biofilm material. Ogle et al. teach (paragraph 93) that biomaterial for leaflets can be crosslinked or under treatment while providing tension to the material. It would have been obvious to one of ordinary skill in the art to crosslink the biofilm while it is under the tensile force to obtain the biofilm material as taught by Ogle et al. in manufacture of the leaflet of Maimon et al. such that the appropriate material properties are established in the leaflet. Maimon et al. also did not explicitly state the direction of tension, being the X direction aligns with a fiber direction of the biofilm. Ogle et al. teach (paragraph 59) that a single or X direction tension can be applied on leaflet biomaterial for orientation of the fibers. It would have been obvious to provide a single X-direction tension on the leaflet biomaterial as taught by Ogle et al. and incorporate in the method of manufacture of valve leaflets by Maimon et al. such that the appropriate flexibility is provided. Regarding claims 2,3, Maimon et al. disclose (paragraph 33) a thickness of the biofilm H1 and that thickness is evaluated after tensile force was applied to establish a second thickness H2 and then assessing a change rate to be (H2-H1)/H1 to be less than 20% and provide thickness value within the range of 2-15%. Regarding claim 4, it is noted that Maimon discloses (paragraph 43) at least one area to be treated in the biofilm which can be one axis or as best understood forces along that axis. Ogle et al. teach (Fig. 5) the at least one area to be treated has two opposite sides serving as force-bearing portions, such that is established the tensile force by two components that are applied in opposite directions to the two sides pulls on one axis. It would have been obvious to one of ordinary skill in the art to utilize two opposite pulling forces on one axis as taught by Ogle et al. with the tissue preparation method of Maimon in order to align fibers with that axis. With respect to claim 5, it can be seen that the area to be treated in the method of Maimon is provided with parallel sides, see Fig. 2. Additionally Ogle et al. teach (Fig. 5) the two sides are located at edge positions of the biofilm and parallel to each other. Regarding claim 6, Maimon discloses (paragraph 47) a plurality of sites are used on sides and also it can be seen (Fig. 9) that Ogle et al. teach each of the two sides (paragraph 59 i.e. opposite directions can be multiple) is fixed as a whole or provided with a plurality of fixing sites 336 spaced apart along an extending direction thereof; and wherein the plurality of fixing sites on a same side are simultaneously applied with force, or separately applied with force based on change in the tensile force. With respect to claim 7, it is noted that Maimon discloses (paragraph 43) at least one area to be treated in the biofilm, the at least one area to be treated has two opposite sides serving as force-bearing portions, and wherein one of the two sides is a stationary edge, other one of the two sides is an opposite movable edge, and the tensile force is applied to the movable edge; or the two sides are both movable edges, and the tensile force comprises two components that are actively applied to each of the movable edges, see Fig 2. Additionally per the teaching of Ogle (paragraph 59) there are two movable sides (Fig. 5) and two stationary sides as force is a single direction, Fig. 9. This is an illustration of force in one direction as Maimon disclosed. With respect to claim 8, Ogle et al. teach that each side is anchored by a connecting member, and the tensile force is applied to the connecting member, paragraphs 19,97. Regarding claim 9, Maimon discloses (paragraph 51) the force is applied to the connecting member by a driving mechanism or a counterweight mechanism and Ogle et al. also teach the force is applied to the connecting member by a driving mechanism or a counterweight mechanism, see Fig. 5 and paragraph 97. Regarding claim 10, Ogle also teaches (paragraph 98) the connecting member is a clamp or a thread. Regarding claim 11, Maimon discloses (paragraph 61) the step of applying the tensile force comprises applying the tensile force until it reaches a first predetermined value or until a deformation amount of the biofilm reaches a second predetermined value. With respect to claim 12, Maimon discloses (paragraph 61) the biofilm has an original first length along the fiber direction, the tensile force is applied to the biofilm until the biofilm reaches a second length along the fiber direction, with a stretching rate of 5% to 15%. Regarding claim 14, Maimon discloses (paragraph 61) tensioning forces are alternately repeated at least twice, with the tensile force applied increasing sequentially when repeating step S200, until the first predetermined value is reached after S200 is performed for a plurality of times. Regarding claim 15, Maimon discloses (paragraph 65) tensioning forces are alternately repeated at least twice, with the deformation amount of the biofilm increasing sequentially when repeating step S200, until the second predetermined value is reached after S200 is performed for a plurality of times. Regarding claim 16, Maimon discloses (paragraphs 54,55) the tensile force is maintained by fixing the biofilm to a supporting mechanism. Regarding claim 18, see abstract of Maimon stating the method produces a biocompatible material. Regarding claim 19, Fig. 1 of Maimon shows a stent of a tubular meshed structure 12, with an interior of the tubular meshed structure defining a blood flow channel; and leaflets 16, mounted within the stent to control an open degree of the blood flow channel, wherein the leaflets are made of the biofilm material. Regarding claim 20, edges of each leaflets comprise: a fixed edge fixed to the stent, and a free edge configured to cooperate with free edges of adjacent leaflets in controlling the blood flow channel (see Fig. 1 of Maimon), and wherein an extending direction of each free edge aligns with a fiber direction (see paragraph 157 of Ogle) of corresponding leaflet.
Claim(s) 13 is rejected under 35 U.S.C. 103 as being unpatentable over Maimon et al. (WO 2019/147585) in view of Ogle et al. (2003/0229394) as applied to claim 1 above, and further in view of Agrawal et al. (WO 2019/165103). Maimon et al. in view of Ogle et al. is explained supra. It is noted Maimon et al. disclose (paragraph 37) the biofilm is immersed in a fixative solution for crosslinking, the fixative solution is at least one of the following: glutaraldehyde aqueous solution, formaldehyde aqueous solution. However, Maimon et al. as modified by Ogle et al. did not explicitly disclose a temperature of the crosslinking treatment is 18 to 26°C, and a period of the crosslinking treatment is 6 to 72 hours. Agrawal et al. teach (page 14, lines 21-26) a tissue treatment temperature of the method for making non-antigenic is within 18 to 26°C, and a period of the treatment is within 6 to 72 hours. It would have been obvious to one of ordinary skill in the art to select the appropriate temperature and time to treat tissue using a temperature within 18 to 26°C, and a period of 6 to 72 hours as taught by Agrawal et al. with the method of preparing tissue of Maimon et al. as modified by Ogle et al. such that the appropriate conditions are provided for tissue properties needed for the desired use.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN E PELLEGRINO whose telephone number is (571)272-4756. The examiner can normally be reached 8:30am-5:00pm M-F.
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/BRIAN E PELLEGRINO/Primary Examiner, Art Unit 3799
