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 .
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 5 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 5 recites that the at least one micro feature has been mechanically formed after coupling the multi-layer barrier to the elastomer body. The specification contains only a bare assertion that this embodiment is possible (see para [0007-0008], [00050], [00074], and [00127]). However, the specification does not describe any mechanical process such as stamping, cutting, scribing, or other physical contact methods) for forming the micro feature on the inner surface of the barrier after that surface has been couple to and hidden by the elastomer body.
The only detailed description of forming the micro feature after coupling is a non-mechanical process in which an energy source is focused toward the inner surface of the first layer by directing two separately angled beams (see para [00081]). All described mechanical formation methods are presented only in the context of forming the micro features prior to coupling the barrier to the elastomer body.
Therefore, the specification fails to demonstrate that the inventor was in possession of a stopper in which the micro feature is mechanically formed after coupling, as recited in claim 5.
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.
Claim 4 is 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.
Regarding claim 4, the phrase "optionally, stamped" renders the claim indefinite because it is unclear whether the phrase limits the intended scope of the claimed invention. See MPEP § 2173.05(d). The claims recites “the at least one micro feature has been mechanically formed (optionally, stamped) and/or thermoformed prior to coupling…” It is unclear whether the term “optionally, stamped” is intended as a required limitation that further narrows the scope of the claim or is merely an exemplary method of mechanical formation. The metes and bounds of the claim are therefor indefinite.
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 1-7, 10-16, 19, and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Ashmead (US Publication No. 2011/0137263), hereinafter, Ashmead, over Spence (US Publication No. 2020/0171202), hereinafter, Spence.
Regarding claim 1, Ashmead discloses a stopper for use in an injector device (syringe stopper comprised of an elastomer body 10 and a fluoropolymer barrier 20 comprising barrier layer 30 and porous layer 40 in fig. 5; para [0026] and [0030]), the stopper having an outer side configured for engagement with an interior bore of a barrel of the injector device (cross-section of stopper depicts syringe barrel 50 engaged with barrier layer in fig. 6; para [0032]), the stopper comprising:
an elastomer body (elastomer body 10 in figs. 5-13; para [0026]);
a multi-layer barrier coupled to the elastomer body (barrier 20 is a multi-layer barrier comprising barrier layer 30 and porous layer 40 coupled to elastomer body 10 in fig. 5; para [0026]), the multi-layer barrier having an inner surface oriented toward the elastomer body (inner surface of barrier 20 material with roughened surface oriented towards elastomer body 10; para [0078]) and an outer surface oriented away from the elastomer body (outer surface of barrier 20 material oriented toward syringe barrel 50 in fig. 6; para [0032]), the multi-layer barrier including a first layer and a second layer, the first layer defining the inner surface and the second layer defining the outer surface (barrier 20 comprises a porous layer 40, which is a first layer defining the inner surface, and barrier layer 30, which is a second layer defining the outer surface in fig. 5; para [0026] and [0030]),
the multi-layer barrier having at least one micro feature formed by the first layer, the at least one micro feature including one or both of a micro groove and/or a micro rib (porous layer 40 inner surface oriented toward elastomer body 10 is roughened by sandblasting which creates micro features; para [0077-0078].
Ashmead does not explicitly disclose that sandblasting to create a roughened surface forms a micro groove.
Spence, however, teaches creating micro grooves using sandblasting (sandblasting is a known manufacturing method of creating microgrooves; para [0024]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sandblasting roughening process of the inner surface of the multi-layer barrier of Ashmead to create micro grooves, as a suggested by Spence, in order to create the desired micro features on the inner surface of the barrier layer to produce hinge points or compliance zones that allow the barrier to bend and conform more uniformly during compression and reduce or eliminate wrinkling on the outer drug-contacting surface of the barrier layer, thereby improving seal integrity and maintaining chemical inertness.
Regarding claim 2, modified Ashmead discloses the stopper of claim 1, wherein the second layer overlays the at least one micro feature formed by the first layer and has a uniform thickness where the second layer overlies the at least one micro feature formed by the first layer (barrier layer 30, which is a second layer defining the outer surface, overlays the microgrooves created in the porous layer 40, which is a first layer defining the inner surface, and has a uniform thickness in figs. 5-13; para [0026] and [0030]).
Regarding claim 3, modified Ashmead discloses the stopper of claim 1, wherein the second layer overlays the at least one micro feature formed by the first layer and is continuous and uninterrupted where the second layer overlies the at least one micro feature formed by the first layer (barrier layer 30, which is a second layer defining the outer surface, overlays the microgrooves created in the porous layer 40, which is a first layer defining the inner surface, and is continuous and uninterrupted in figs. 5-13; para [0026] and [0030]).
Regarding claim 4, modified Ashmead discloses the stopper of claim 1,wherein the at least one micro feature has been mechanically formed (optionally, stamped) and/or thermoformed prior to coupling the multi-layer barrier to the elastomer body (porous layer 40 is roughened by sandblasting, which creates microgrooves, prior to thermoforming; para [0077-0078]; Spence teaches that sandblasting is a known manufacturing method of creating microgrooves; para [0024]; as noted in claim 1 modified device of Ashmead, using sandblasting to create a roughened surface, specifically micro-grooves, provides localized hinge points/compliance zones on the inner surfacer of the barrier layer that reduce wrinkling and improves deformation under compression in the syringe barrel).
Regarding claim 5, modified Ashmead discloses the stopper of claim 1, wherein the at least one micro feature has been mechanically formed after coupling the multi-layer barrier to the elastomer body (porous layer 40 is roughened by sandblasting, which creates microgrooves, prior to thermoforming; para [0077-0078]; Spence teaches that sandblasting is a known manufacturing method of creating microgrooves; para [0024]; ; as noted in claim 1 modified device of Ashmead, using sandblasting to create a roughened surface, specifically micro-grooves, provides localized hinge points/compliance zones on the inner surfacer of the barrier layer that reduce wrinkling and improves deformation under compression in the syringe barrel).
The limitation in claim 5 that the micro feature is “mechanically formed after coupling the multi-layer barrier to the elastomer body” is a process limitation. Pursuant to MPEP 2113(I), the patentability of a product claim does not depend on its method of production. Because modifies Ashmead renders obvious the final stopper structure recited in claim 1, claim 5 is also rendered obvious regardless of when or how the micro feature is formed.
This product claim remains subject to paragraph 3 of this Office Action, which addresses a separate statutory requirement.
Regarding claim 6, modified Ashmead discloses a method of forming a stopper for use in an injector device (syringe stopper comprised of an elastomer body 10 and a fluoropolymer barrier 20 comprising barrier layer 30 and porous layer 40 in fig. 5; para [0026] and [0030]), the stopper having an outer side configured for engagement with an interior bore of a barrel of the injector device (outer surface of barrier 20 material oriented toward syringe barrel 50 in fig. 6; para [0032]), the method comprising:
forming at least one surface feature on an inner surface of a barrier (porous layer 40 inner surface, oriented toward elastomer body 10, is roughened by sandblasting which creates microgrooves; para [0077-0078]; Spence teaches that sandblasting is a known manufacturing method of creating microgrooves; para [0024]), the at least one surface feature including one or both of:
a raised area such that the barrier defines a relatively greater thickness at the raised area than surrounding portions of the barrier (roughening the inner surface by sandblasting creates microgrooves which results in raised areas due to physical material removal in adjacent areas; para [0077-0078]), and/or
a depressed area such that the barrier defines a relatively lesser thickness at the depressed area than surrounding portions of the barrier (roughening the inner surface by sandblasting creates microgrooves which results in depressed areas due to physical material removal; para [0077-0078]); and
coupling the barrier to an elastomer body (composite barrier is made by laminating porous layer to barrier layer using this layer of adhesive; para [0047]) with the inner surface oriented toward the elastomer body and an outer surface of the barrier oriented away from the elastomer body (inner surface of barrier 20 material with roughened surface oriented towards elastomer body 10; para [0078]; outer surface of barrier 20 material oriented toward syringe barrel 50 and away from elastomer body 10 in fig. 6; para [0032]).
Regarding claim 7, modified Ashmead discloses the method of claim 6, wherein the at least one surface feature includes one or both of a micro rib and a micro groove (porous layer 40 inner surface is roughened by sandblasting which creates microgrooves; para [0077-0078]; Spence teaches that sandblasting is a known manufacturing method of creating microgrooves; para [0024]).
Regarding claim 10, modified Ashmead discloses the method of claim 6, wherein forming the at least one surface feature includes at least one of mechanically forming (optionally, stamping), thermoforming, depositing, coating, and/or molding the at least one surface feature on the inner surface of the barrier (porous layer 40 inner surface is roughened by sandblasting which creates microgrooves; para [0077-0078]; Spence teaches that sandblasting is a known manufacturing method of creating microgrooves; para [0024]).
Regarding claim 11, modified Ashmead discloses the method of claim 6, wherein the barrier is a multi-layer barrier including a first layer and a second layer, the first layer defining the inner surface and the second layer defining the outer surface of the barrier (barrier 20 comprises a porous layer 40, which is a first layer defining the inner surface, and barrier layer 30, which is a second layer defining the outer surface in fig. 5; para [0026] and [0030]).
Regarding claim 12, modified Ashmead discloses the method of claim 6, wherein the at least one surface feature is formed on the inner surface of the barrier prior to coupling the barrier to the elastomer body (porous layer 40 is roughened by sandblasting, which creates microgrooves, prior to thermoforming; para [0077-0078]; Spence teaches that sandblasting is a known manufacturing method of creating microgrooves; para [0024]).
Regarding claim 13, modified Ashmead discloses the method of claim 6, wherein the at least one surface feature is formed on the inner surface of the barrier after coupling the barrier to the elastomer body (porous layer 40 is roughened by sandblasting, which creates microgrooves; para [0077-0078]; Spence teaches that sandblasting is a known manufacturing method of creating microgrooves; para [0024]).
Regarding claim 14, modified Ashmead discloses a stopper for use in an injector device (syringe stopper comprised of an elastomer body 10 and a fluoropolymer barrier 20 comprising barrier layer 30 and porous layer 40 in fig. 5; para [0026] and [0030]), the stopper having an outer side configured for engagement with an interior bore of a barrel of an injector device (cross-section of stopper depicts syringe barrel 50 engaged with barrier layer in fig. 6; para [0032]), the stopper comprising:
an elastomer body (elastomer body 10 in figs. 5-13; para [0026]);
a barrier coupled to the elastomer body (barrier 20 is a multi-layer barrier comprising barrier layer 30 and porous layer 40 coupled to elastomer body 10 in fig. 5; para [0026]), the barrier having an inner surface oriented toward the elastomer body (inner surface of barrier 20 material with roughened surface oriented towards elastomer body 10; para [0078]) and an outer surface oriented away from the elastomer body (outer surface of barrier 20 material oriented toward syringe barrel 50 and away from elastomer body 10 in fig. 6; para [0032]), the inner surface of the barrier having at least one depressed area formed into the inner surface of the barrier such that the barrier defines a relatively smaller thickness at the depressed area than surrounding portions of the barrier (roughening the inner surface by sandblasting creates microgrooves which results in depressed areas that define portions of relatively smaller thickness due to physical material removal; para [0077-0078]).
Regarding claim 15, modified Ashmead discloses the stopper of claim 14, wherein the at least one depressed area on the inner surface includes a micro groove (roughening the inner surface by sandblasting creates microgrooves which results in depressed areas that define relatively smaller thickness portions due to physical material removal; para [0077-0078]).
Regarding claim 16, modified Ashmead discloses the stopper of claim 14, wherein the at least one depressed area on the inner surface includes one or more thinner regions of the barrier (roughening the inner surface by sandblasting creates microgrooves which results in depressed areas that define relatively smaller thickness portions due to physical material removal; para [0077-0078]).
Regarding claim 19, modified Ashmead discloses a stopper for use in an injector device (syringe stopper comprised of an elastomer body 10 and a fluoropolymer barrier 20 comprising barrier layer 30 and porous layer 40 in fig. 5; para [0026] and [0030]), the stopper having an outer side configured for engagement with an interior bore of a barrel (cross-section of stopper depicts syringe barrel 50 engaged with barrier layer in fig. 6; para [0032]), the stopper comprising:
an elastomer body (elastomer body 10 in figs. 5-13; para [0026]); and
a multi-layer barrier coupled to the elastomer body (barrier 20 is a multi-layer barrier comprising barrier layer 30 and porous layer 40 coupled to elastomer body 10 in fig. 5; para [0026]), the multi-layer barrier including a first layer and a second layer (barrier 20 comprises a porous layer 40, which is a first layer defining the inner surface, and barrier layer 30, which is a second layer defining the outer surface in fig. 5; para [0026] and [0030]), the first layer having one or more discontinuous portions (porous layer 40 inner surface oriented toward elastomer body 10 is roughened by sandblasting which creates discontinuous microgrooves; para [0077-0078]; Spence teaches that sandblasting is a known manufacturing method of creating microgrooves; para [0024]) and the second layer overlying the one or more discontinuous portions (barrier layer 30, which is a second layer defining the outer surface, overlays the discontinuous microgrooves created in porous layer 40 in figs. 5-13; para [0026] and [0030]).
Regarding claim 28, modified Ashmead discloses the stopper of claim 20, wherein the first layer includes a micro rib and/or a microgroove (porous layer 40 inner surface oriented toward elastomer body 10 is roughened by sandblasting which creates microgrooves; para [0077-0078]; Spence teaches that sandblasting is a known manufacturing method of creating microgrooves; para [0024]).
Claims 8-9, 17-18, 20-27, and 29-31 are rejected under 35 U.S.C. 103 as being unpatentable over Ashmead in view of Spence, as applied to claims 1 and 6 above, and further in view of Kaneko (US Publication No. 2017/0281873), hereinafter, Kaneko.
Regarding claim 8, modified Ashmead discloses the method of claim 6, with at least one surface feature of raised areas each defining a relatively greater thickness than surrounding portions of the barrier (porous layer 40 inner surface is roughened by sandblasting which creates microgrooves which include both raised areas with a greater material thickness and depressed areas with relatively lesser thickness; para [0077-0078]; Spence teaches that sandblasting is a known manufacturing method of creating microgrooves; para [0024]).
Ashmead fails, however, to disclose that the surface features form a pattern.
Kaneko teaches a pattern of raised and depressed areas defining relatively greater and lesser thicknesses than surrounding portions of the barrier (Kaneko shows formation of grooves is achieved by the cutting of the laser beam application which is properly selected according to the forming conditions of the groove and, particularly, the application of short pulse laser beams; para [0081]; the pulsed laser beam is applied while rotating the gasket as shown in fig. 4 and can form broken or non-uniform segments in figs. 5-8).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to arrange the micro-scale surface features of Ashmead into the organized pattern of raised and depressed areas, or ribs and grooves, as taught by Kaneko, in order to achieve more uniform deformation around the circumference of the stopper during compression.
Regarding claim 9, modified Ashmead discloses the method of claim 6, wherein the at least one surface feature includes a pattern of depressed areas each defining a relatively lesser thickness than surrounding portions of the barrier (porous layer 40 inner surface is roughened by sandblasting which creates microgrooves which include both raised areas with a greater material thickness and depressed areas with relatively lesser thickness; para [0077-0078]; Spence teaches that sandblasting is a known manufacturing method of creating microgrooves; para [0024]; Kaneko shows formation of grooves is achieved by the cutting of the laser beam application which is properly selected according to the forming conditions of the groove and, particularly, the application of short pulse laser beams; para [0081]; the pulsed laser beam is applied while rotating the gasket as shown in fig. 4 and can form patterned discontinuous grooves in figs. 5-8).
Regarding claim 17, modified Ashmead discloses a stopper for an injector device (syringe stopper comprised of an elastomer body 10 and a fluoropolymer barrier 20 comprising barrier layer 30 and porous layer 40 in fig. 5; para [0026] and [0030]), the stopper comprising:
a body (elastomer body 10 in figs. 5-13; para [0026]); and
a barrier coupled to the body (barrier 20 is a multi-layer barrier comprising barrier layer 30 and porous layer 40 coupled to elastomer body 10 in fig. 5; para [0026])
Ashmead fails, however, to disclose the barrier having an outer surface defining a micro groove, the barrier at the micro groove being continuous and uninterrupted, and being relatively thinner than the barrier is at surrounding portions of the barrier.
Kaneko teaches the barrier having an outer surface defining a micro groove (Kaneko: annular groove 22 formed on the outer circumferential surface of the lamination film 15 in figs. 2-3; para [0046]), the barrier at the micro groove being continuous and uninterrupted (Kaneko: lamination film 15 remains continuous and uninterrupted at annular groove 22 in fig. 3), and being relatively thinner than the barrier is at surrounding portions of the barrier (Kaneko: groove 22 creates a depression where lamination film 15 is thinner than the surrounding portions of the film in fig. 3
Regarding claim 18, modified Ashmead discloses the injector device stopper of claim 17, wherein the micro groove defines a discontinuous, broken, circumferential line pattern (Kaneko: formation of grooves is achieved by the cutting of the laser beam application which is properly selected according to the forming conditions of the groove and, particularly, the application of short pulse laser beams; para [0081]; the pulsed laser beam is applied while rotating the gasket as shown in fig. 4 and can form broken and discontinuous grooves in figs. 5-8).
Regarding claim 20, modified Ashmead discloses a stopper for use in an injector device (syringe stopper comprised of an elastomer body 10 and a fluoropolymer barrier 20 comprising barrier layer 30 and porous layer 40 in fig. 5; para [0026] and [0030]), the stopper having an outer side configured for engagement with an interior bore of a barrel (cross-section of stopper depicts syringe barrel 50 engaged with barrier layer in fig. 6; para [0032]), the stopper comprising:
an elastomer body (elastomer body 10 in figs. 5-13; para [0026]); and
a multi-layer barrier coupled to the elastomer body (barrier 20 is a multi-layer barrier comprising barrier layer 30 and porous layer 40 coupled to elastomer body 10 in fig. 5; para [0026]), the multi-layer barrier including a first layer and a second layer (barrier 20 comprises a porous layer 40, which is a first layer defining the inner surface, and barrier layer 30, which is a second layer defining the outer surface in fig. 5; para [0026] and [0030]), the second layer having one or more discontinuous portions (Kaneko: formation of grooves 22 is achieved by the cutting of the laser beam application which is properly selected according to the forming conditions of the groove and, particularly, the application of short pulse laser beams; para [0081]; the pulsed laser beam is applied while rotating the gasket as shown in fig. 4 and can form broken and discontinuous grooves in figs. 5-8) and the first layer extending across the one or more discontinuous portions and the elastomer body (when combined with Kaneko’s discontinuous groove 22 portions, Ashmead’s porous layer 40, which is a first layer defining the inner surface, extends across barrier layer 30 and elastomer body 10 in fig. 5).
Regarding claim 21, modified Ashmead discloses the stopper of claim 20, wherein the one or more discontinuous portions of the second layer are defined by at least one micro groove (Kaneko: formation of grooves is achieved by the cutting of the laser beam application which is properly selected according to the forming conditions of the groove 22 and, particularly, the application of short pulse laser beams; para [0081]; the pulsed laser beam is applied while rotating the gasket as shown in fig. 4 and can form broken and discontinuous grooves in figs. 5-8) and the first layer provides an uninterrupted barrier between elastomer body and the at least one micro groove (modified Ashmead’s porous layer 40, which is a first layer defining the inner surface, extends across barrier layer 30 and elastomer body 10 in fig. 5).
Regarding claim 22, modified Ashmead discloses the stopper of claim 20, but fails to disclose that the first layer is exposed through the second layer to define at least a portion of the outer side of the stopper.
Kaneko teaches a first layer exposed through a second layer to define at least a portion of the outer side of the stopper (Kaneko: groove can be formed with a depth greater than the thickness (T) of the lamination film 15 which; para [0050]; when combined with Ashmead’s multilayer barrier, is capable of exposing the first layer through the second layer to define a portion of the outer side of elastomer body 10).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to form the discontinuous portions of the second layer of modified Ashmead with a depth greater than the film thickness, as taught by Kaneko, such that the first layer is exposed through the second layer on the outer side in order to achieve the desired localized compliance and sealing performance while allowing the first layer to contribute to the outer surface properties.
Regarding claim 23, modified Ashmead discloses the stopper of claim 20, wherein the one or more discontinuous portions result in the second layer being less resistant to tearing than the first layer at the one or more discontinuous portions (Kaneko: creation of grooves 22 thins the second layer at those locations, making the second layer less resistant to tearing at the discontinuous portions; para [0051]; concurrently, Ashmead’s first layer remains intact and continuous while providing greater tear resistance).
Regarding claim 24, modified Ashmead discloses the stopper of claim 20, wherein the first layer is formed of a microporous layer (porous layer 40 in fig. 5; para [0030]) having a greater strength than the second layer where the first layer extends across the one or more discontinuous portions (thickness of both densified PTFE and porous PTFE layers are suitably tailored to the application to ensure compliance and sealability while retaining sufficient strength; para [0038-0039]).
Regarding claim 25, modified Ashmead discloses the stopper of claim 20, wherein the first layer includes a densified fluoropolymer (in multi-layer embodiments, each layer may contribute different properties and functions regardless of its designation as a barrier layer or otherwise, and the barrier may comprise multiple barrier layers or multiple porous layers that can be suitably tailored to allow optimal compliance through the properties of thin films; para [0025] and [0050]).
Regarding claim 26, modified Ashmead discloses the stopper of claim 20, wherein the first layer includes a thermoplastic material (in multi-layer embodiments, each layer may contribute different properties and functions regardless of its designation as a barrier layer or otherwise, and the barrier may comprise multiple barrier layers or multiple porous layers that can be suitably tailored to allow optimal compliance through the properties of thin films; para [0025] and [0050]).
Regarding claim 27, modified Ashmead discloses the stopper of claim 20, wherein the first layer includes an elastomeric material (in multi-layer embodiments, each layer may contribute different properties and functions regardless of its designation as a barrier layer or otherwise, and the barrier may comprise multiple barrier layers or multiple porous layers that can be suitably tailored to allow optimal compliance through the properties of thin films; para [0025] and [0050]).
Regarding claim 29, modified Ashmead discloses the stopper of claim 20, wherein the discontinuous portion of the second layer includes a micro rib and/or a micro groove (Kaneko: formation of grooves 22 is achieved by the cutting of the laser beam application which is properly selected according to the forming conditions of the groove and, particularly, the application of short pulse laser beams; para [0081]; the pulsed laser beam is applied while rotating the gasket as shown in fig. 4 and can form broken and discontinuous grooves in figs. 5-8).
Regarding claim 30, modified Ashmead discloses the stopper of claim 20, wherein the second layer is non-porous (barrier layer 30 can be comprised of densified ePTFE; para [0030]).
Regarding claim 31, modified Ashmead discloses the stopper of claim 20, wherein the second layer is polytetrafluoroethylene (barrier layer 30 can be comprised of densified ePTFE; para [0030]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZACHARIAH K WHITROCK whose telephone number is (571)272-3534. The examiner can normally be reached Monday - Friday 8:00 am - 5:00 pm.
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/ZACHARIAH K WHITROCK/Patent Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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