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 .
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.
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 30 and 44 recite the limitation " the material comprises silicone foam rubber ". The independent claims recite that the material must be a “non-porous, non-organic polymer”. The term “foam” appears to contradict the term “non-porous”, since a foam material is porous. Therefore, the limitations of claims 30 and 44 are being interpreted as reciting "the material comprises silicone rubber".
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.
Claim(s) 26-46 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Stevenson (20200330213).
With regards to claim 26, Stevenson discloses a tubular or non-tubular implant or prosthetic (10) comprising: a textile layer ([0379], “the conduit 10 is a woven, fibrous polymer conduit 10”) comprising a plurality of interstices and/or pores (10e, [0098], [0379]), and defining an interfacing surface (10a) and an opposing surface (10b); and a sealing layer (14) comprising a non-porous, non-organic polymer ([0401], silicone elastomer) adhered to the interfacing surface and defining a tissue-facing surface (FIG 1c), wherein the non-porous, non-organic polymer is configured to at least partially penetrate through at least some of the plurality of interstices and/or pores at the interfacing surface of the textile layer ([0646], “two mechanisms by which silicone penetrated into the inner surface of the fabric were observed, i.e., either through the yarn bundle fibers or by passing between the gaps in the yarn bundles.”), wherein the non-porous, non-organic polymer is formed of a material capable of preventing electrocautery energy applied thereto from damaging the textile layer ([0401], [0467]). Applicant has explained in paragraph 82 that silicone is virtually impervious to energy applied by electrocautery techniques/ energy.
With regards to claim 27, Stevenson discloses the tubular or non-tubular implant or prosthetic of claim 26, wherein the material of the non-porous, non-organic polymer of the sealing layer is impervious to electrocautery energy applied thereto ([0401], [0467], silicone does not conduct electricity and therefore is impervious to electrocautery energy).
With regards to claim 28, Stevenson discloses the tubular or non-tubular implant or prosthetic of claim 26, wherein the material of the non-porous, non-organic polymer of the sealing layer is configured to prevent electrocautery energy applied thereto from damaging the textile layer when an electrocautery device applying the electrocautery energy is operated at any power or voltage level ([0401], [0467], silicone does not conduct electricity, and therefore is impervious to electrocautery energy).
With regards to claim 29, Stevenson discloses the tubular or non-tubular implant or prosthetic of claim 26, wherein the material comprises silicone ([0467]).
With regards to claim 30, Stevenson discloses the tubular or non-tubular implant or prosthetic of claim 26, wherein the material comprises silicone rubber ([0467]).
With regards to claim 31, Stevenson discloses the tubular or non-tubular implant or prosthetic of claim 26, wherein the material defines a molecular bond energy higher than 355 kJ/mol ([0467], rubber silicone contains at least an Si-O-Si bond (see Applicant’s specification at paragraph 113), which has a molecular bond energy of at least 433kJ/mol, therefore the whole material will have a molecular bond energy higher than 355kJ/mol).
With regards to claim 32, Stevenson discloses the tubular or non-tubular implant or prosthetic of claim 26, wherein the material of the non-porous, non-organic polymer of the sealing layer is configured to resist heat transfer to the textile layer from heat applied to the sealing layer ([0467], silicone rubber is a thermal insulator and therefore capable of resisting heat transfer).
With regards to claim 33, Stevenson discloses the tubular or non-tubular implant or prosthetic of claim 26 comprising a cross- section formed of at least a first zone, a second zone, and a third zone (FIG 17), wherein the first zone is within the textile layer and is bounded on a first side by the opposing surface of the textile layer (FIG 17) and wherein the plurality of interstices and/or pores within the first zone do not comprise any of the non-porous, non-organic polymer of the sealing layer ([0699], “The fiber bundles 58 at the inner textile surface 54 were free from silicone sealant 56”), wherein the second zone is within the textile layer and located adjacent to and bounded on a first side by the first zone and on an opposing side by the interfacing surface (FIG 17), wherein the plurality of interstices and/or pores within the second zone comprise at least some of the non- porous, non-organic polymer ([0699], “the silicone sealant 56 penetrated and encapsulated the textile fiber bundles 58 at the outer textile surface”), wherein the third zone is within the sealing layer and is located adjacent to and bounded on a first side by the interfacing surface of the textile layer and on an opposing side by the tissue- facing surface of the sealing layer (FIG 17), and wherein the material of the non-porous, non-organic polymer is configured to prevent the electrocautery energy applied to the tissue-facing surface of the sealing layer from damaging at least the first zone ([0401], [0467]). Applicant has explained in paragraph 82 that silicone is virtually impervious to energy applied by electrocautery techniques/ energy.
With regards to claim 34, Stevenson discloses the tubular or non-tubular implant or prosthetic of claim 33, wherein the material of the non-porous, non-organic polymer is configured to prevent the electrocautery energy applied to the tissue-facing surface of the sealing layer from damaging at least the first zone and the second zone ([0401], [0467], silicone does not conduct electricity, and therefore is impervious to electrocautery energy).
With regards to claim 35, Stevenson discloses the tubular or non-tubular implant or prosthetic of claim 26, wherein the non- porous, non-organic polymer of the sealing layer does not penetrate to the opposing surface of the textile layer (FIG 14, [0688], “Individual textile bundles 58 were general free of silicone sealant penetration”).
With regards to claim 36, Stevenson discloses the tubular or non-tubular implant or prosthetic of claim 26, wherein at least some of the non-porous, non-organic polymer of the sealing layer penetrates to the opposing surface of the textile layer (FIG 12, [0677], “Fiber bundles 58A were fully encapsulated by the silicone sealant 56”).
With regards to claim 37, Stevenson discloses the tubular or non-tubular implant or prosthetic of claim 26, wherein the material of the non-porous, non-organic polymer is configured to prevent bacteria from adhering to the tissue-facing surface ([0467], silicone rubber is chemically inert and hydrophobic, preventing bacteria from adhering at least to some degree).
With regards to claim 38, Stevenson discloses the tubular or non-tubular implant or prosthetic of claim 26, wherein the material of the non-porous, non-organic polymer is configured to prevent seromas from forming on the tissue-facing surface ([0467], silicone rubber is chemically inert and hydrophobic, preventing seromas from forming at least to some degree).
With regards to claim 39, Stevenson discloses the tubular or non-tubular implant or prosthetic of claim 26, wherein the material of the non-porous, non-organic polymer is configured to prevent infection from forming on the tissue-facing surface ([0467], silicone rubber is chemically inert and hydrophobic, preventing bacteria from adhering, and therefore infection from forming at least to some degree ).
With regards to claim 40, Stevenson discloses a tubular or non-tubular implant or prosthetic comprising: a textile layer ([0379], “the conduit 10 is a woven, fibrous polymer conduit 10”) comprising a plurality of interstices and/or pores (10e, [0098], [0379]), and defining an interfacing surface (10a) and an opposing surface (10b); and a sealing layer (14) comprising a non-porous, non-organic polymer ([0401], silicone elastomer) attached to the interfacing surface and defining a tissue-facing surface (FIG 1c), wherein the non-porous, non-organic polymer is configured to at least partially penetrate through at least some of the plurality of interstices and/or pores at the interfacing surface of the textile layer ([0646], “two mechanisms by which silicone penetrated into the inner surface of the fabric were observed, i.e., either through the yarn bundle fibers or by passing between the gaps in the yarn bundles.”), wherein the non-porous, non-organic polymer is formed of a material capable of preventing electrocautery energy applied to or near the tissue-facing surface from damaging the textile layer ([0401], [0467]). Applicant has explained in paragraph 82 that silicone is virtually impervious to energy applied by electrocautery techniques/ energy.
With regards to claim 41, Stevenson discloses the tubular or non-tubular implant or prosthetic of claim 40, wherein the material of the non-porous, non-organic polymer of the sealing layer is impervious to electrocautery energy applied thereto ([0401], [0467], silicone does not conduct electricity and therefore is impervious to electrocautery energy at least to some degree ).
With regards to claim 42, Stevenson discloses the tubular or non-tubular implant or prosthetic of claim 40, wherein the material of the non-porous, non-organic polymer of the sealing layer is configured to prevent electrocautery energy applied to or near the tissue-facing surface from damaging the textile layer when an electrocautery device applying the electrocautery energy is operated at any power or voltage level ([0401], [0467], silicone does not conduct electricity and therefore is impervious to electrocautery energy at least to some degree).
With regards to claim 43, Stevenson discloses the tubular or non-tubular implant or prosthetic of claim 40, wherein the material comprises silicone ([0467]).
With regards to claim 44, Stevenson discloses the tubular or non-tubular implant or prosthetic of claim 40, wherein the material comprises silicone rubber ([0467]).
With regards to claim 45, Stevenson discloses the tubular or non-tubular implant or prosthetic of claim 40, wherein the material defines a molecular bond energy higher than 355 kJ/mol ([0467], rubber silicone contains at least an Si-O-Si bond, which has a molecular bond energy of at least 433kJ/mol, therefore the whole material will have a molecular bond energy higher than 355kJ/mol).
With regards to claim 46, Stevenson discloses a tubular or non-tubular implant or prosthetic (10) configured to resist or retard damage due to application of electrocautery energy ([0401], [0467], silicone does not conduct electricity and therefore is impervious to electrocautery energy), comprising: a textile layer ([0379], “the conduit 10 is a woven, fibrous polymer conduit 10”) comprising a plurality of interstices and/or pores (10e, [0098], [0379]), and defining an interfacing surface (10a) and an opposing surface (10b); and a sealing layer (14) of a non-porous, non-organic polymer ([0401], silicone elastomer) attached to the interfacing surface and defining a tissue-facing surface (FIG 1c), wherein the non-porous, non-organic polymer is configured to at least partially penetrate through at least some of the plurality of interstices and/or pores at the interfacing surface of the textile layer ([0646], “two mechanisms by which silicone penetrated into the inner surface of the fabric were observed, i.e., either through the yarn bundle fibers or by passing between the gaps in the yarn bundles.”), wherein the non-porous, non-organic polymer of the sealing layer does not penetrate to the opposing surface of the textile layer (FIG 14, [0688], “Individual textile bundles 58 were general free of silicone sealant penetration”), wherein the sealing layer is configured to resist and/or retard damage from applied electrosurgical energy, whereby damage to the textile layer resulting from the applied electrosurgical energy is resisted and/or retarded ([0401], [0467]). Applicant has explained in paragraph 82 that silicone is virtually impervious to energy applied by electrocautery techniques/ energy.
Conclusion
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/R.F.N./Patent Examiner, Art Unit 3774
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774
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