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 .
Applicant’s election, with traverse, of Group I claims 1-14 directed to a tissue scaffold is acknowledged. Applicant argues that the search and examination of all claims in the application can be made without serious burden to the Examiner. The claims in Groups I and II are two (2) separate and distinct inventions. The tissue scaffold of claims 1-14 is a product which can be made by a different process such as a picking mechanism. Groups I and II are classified in two different classification areas which would require different search strategies. Applicant’s argument is not persuasive. The restriction is deemed proper and thus made FINAL.
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.
Claims 1-14 are rejected under 35 U.S.C. 103 as being unpatentable over Du, U.S. Pre Grant Publication 2012/0165918.
Regarding claim 1 and 7-11, Du discloses a woven prosthesis from warp and weft yarns [abstract]. Paragraph 0012 discloses base warp yarns interwoven with weft passes wherein the woven base forms smaller and larger diameter portions of the prothesis. Paragraph 0169 discloses that the yarns can include polyethylene terephthalate polyesters. Additionally, paragraph 0169 discloses that the yarns may be comprised of single or multiple plies. It is also disclosed in paragraph 0169 that the yarns may have a denier in the range of 15 to 300.
Du is silent to the textile having a plurality of pores having a size ranging from 100 µm to 800 µm. Paragraph 0104 discloses that the prosthesis is configured to resist a predetermined level of blood leakage wherein the leakage rate can be controlled by adjusting the porosity to provide for uniform porosity sufficient to provide for tissue growth. The pore size is an optimizable feature. One of ordinary skill in the art before the effective filing date of the invention would optimize the pore size in the prothesis to 100 µm to 800 µm to control the blood leakage rate.
Regarding claim 2, Du discloses in Figure 1 and paragraph 0103 an area ratio of the first portion 12 to the second portion 14 in the range of 1:1 and 20:1
Regarding claim 3, Du is silent to the textile having an overall porosity of between 5% and 62%. Paragraph 0104 discloses that the prosthesis is configured to resist a predetermined level of blood leakage wherein the leakage rate can be controlled by adjusting the porosity to provide for uniform porosity sufficient to provide for tissue growth. One of ordinary skill in the art before the effective filing date of the invention would optimize the porosity of the woven prosthesis to a range of 5% to 62% to provide for uniform porosity sufficient to provide for tissue growth.
Regarding claim 4, Du is silent to a porosity of the textile in the first region is greater than or equal to a porosity of the textile in the second region. Paragraph 0104 discloses that the prosthesis is configured to resist a predetermined level of blood leakage wherein the leakage rate can be controlled by adjusting the porosity to provide for uniform porosity sufficient to provide for tissue growth. One of ordinary skill in the art before the effective filing date of the invention would optimize the porosity of the first region is greater than or equal to a porosity of the textile in the second region in order to provide sufficient tissue growth.
Regarding claim 5, Du is silent to the porosity of the textile in the first region 12 is between 5% and 65%. Paragraph 0112 of Du discloses that it is desirable to have a reduced porosity in the second portion as compared to the first woven tubular portion while maintaining the porosity above a level allowing for blood leakage. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to optimize the porosity of the first region to a porosity of between 5% and 65% for the benefit of maintaining the porosity above a level allowing for blood leakage.
Regarding claim 6, Du is silent to the porosity of the textile in the second region 14 is between 2% and 30%. Paragraph 0112 of Du discloses that it is desirable to have a reduced porosity in the second portion as compared to the first woven tubular portion while maintaining the porosity above a level allowing for blood leakage. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to optimize the porosity of the second region to a porosity of between 2% and 30% for the benefit of maintaining the porosity above a level allowing for blood leakage.
Regarding claim 12, paragraph 0175 discloses that the first portion has corrugated sections [pleated/folded].
Regarding claim 13, Figure 9 shows the first region 12 is located at the exterior and the second region 14 is located at an anterior of the structure.
Regarding claim 14, Du discloses in paragraph 0137 a first portion 12 between two second portions 14 and 16.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CAMIE S THOMPSON whose telephone number is (571)272-1530. The examiner can normally be reached 8:30 am - 5:30 pm.
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/CAMIE S THOMPSON/Primary Examiner, Art Unit 1786
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