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 .
Response to Arguments
Applicant's arguments filed 05/21/26 have been fully considered but they are not persuasive.
On page 6 regarding drawing objections Applicant argues the claimed subject matter need not be illustrated since a person of ordinary skill would understand the invention without illustrating the adhesive.
The Examiner respectfully agrees and withdraws the drawing objection.
On page 6 regarding objections to the specification, Applicant argues [0082]-[0083] describes the “first structural component” and the “second structural component”.
The Examiner respectfully disagrees, noting these phrases cannot be found in the specification, as filed.
On page 7 regarding prior art rejections, Applicant argues amendments overcome the rejection of record.
The Examiner respectfully disagrees and maintains the prior art teaches the invention as is claimed.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: the structure including a first structural component and a second structural component.
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 1-2, 4, 8, 23, 27-28, 15 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 pre-AIA the applicant regards as the invention.
Claim 1 is indefinite for claiming the membrane has a “porous microstructure” defined by the ePTFE, the membrane “maintain structure” (sic) in response to fracture/degradation of the filament, and the membrane “including a second scaffold defined by a first structural component…and a second structural component”. Notably, it appears the membrane requires 4 distinct items: (1) a porous microstructure (ePTFE), (2) fragments of the filament, (and a second scaffold which includes both) (3) a degradable first structural component and (4) a second structural component that is non-degradable.
However, the specification [0082] indicates that the membrane is “formed of a scaffold structure…components”. This appears to indicate that the membrane includes only the two structural components (3) and (4) above. The specification [0083] further states that the one of the components stabilizes and the other component can degrade. This makes it unclear where the other two elements of the membrane (the porous microstructure (1) and fragments of the filament (2)) are. They do not appear to be pictured in the figures, and the description makes the Examiner think that the membrane only includes those two structural components (3) and (4). The specification [0055] also states that the membrane IS a non-degradable polymer such as ePTFE. Thus, it is possible that amended claims are attempting to claim two embodiments within one claim, or possible that some of the various recitations are claimed differently but are actually the same thing (e.g. maybe the microstructure is part of the membrane, but one of the structural components are part of the microstructure). The Examiner is unclear on how to interpret this claim for the purposes of examination.
The claim is likewise indefinite for claiming the fragments of the filament are a part of the membrane itself. Since the claim positively recites the filament and membrane as being two distinct elements of the medical device, it is unclear how the filament can be claimed as both a separate element from the membrane (“a medical device comprising: at least one filament… [and] a membrane arranged about the at least one filament”), as well as a part of the membrane (the membrane containing fragments of the filament”). It is unclear how both can be possible at the same time.
Claim 27 makes this point further unclear, since it claims the first and second structural components “define a porosity”. It is unclear how, if at all, the porosity is the same or different from the previously claimed “porous microstructure”. This recitation makes the Examiner more unclear on how the two structural components (3), (4) relate to the membrane as a whole, the porous microstructure (1), and the fragments (2).
Claim 15 is indefinite for also making it unclear how, if at all, the “scaffold structure”, “porous microstructure”, and “first” and “second structural components” are related for the same reasons as claim 1 above.
Remaining claims are rejected for depending on an indefinite claim.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-2, 4, 8, 15, 23-24, 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mangiardi (US 20140356407 A1) in view of Armstrong et al. (US 20120303112 A1) hereinafter known as Armstrong.
Regarding claim 1, Mangiardi discloses a medical device ([0002]) comprising:
a filament (Figure 2a item 21) which is degradable (abstract) and defines a first scaffold (Figure 1 and [0005]); and
a membrane arranged about the filament (Figure 2a item 23) the membrane being configured to contain fragments of the filament and maintain structure of the first scaffold in response to the fracture or degradation of the filament (the applicant is advised that, while the features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function. In addition, it has been held by the courts that apparatus claims cover what a device is, not what a device does. See MPEP 2144 (I). In this case, the patented apparatus of Mangiardi discloses (as detailed above) all the structural limitations required to perform the recited functional language, therefore was considered to anticipate the claimed apparatus. See also [0004], [0050], [0087]), the membrane including a second scaffold (Applicant’s specification has defined this as being “woven, knitted, non-woven, absorbable, or non-absorbable” ([00082]). Since the membrane 23 is woven or non-woven, it meets the limitation. Alternatively, the Examiner refers back to Figure 2 item 23, where the coating surrounding the core 21 is its own framework with the core located therein, and alternatively again, at the Combination below)
but is silent with regards to the membrane having a porous microstructure defined by ePTFE, the membrane’s second scaffold being defined by a first structural component which is degradable and a second structural component that is non-degradable,
and an adhesive for coupling the membrane to the filament.
However, regarding claim 1 Armstrong teaches medical devices can include a membrane material ([0059] covering) which has a porous microstructure defined by ePTFE ([0059]) which can include a first structural component which is degradable ([0114] a therapeutic agent with a degradable polymer agent) and a second structural component which is non-degradable ([0114], [0059] ePTFE), and an adhesive coupling the membrane to the underlying scaffold ([0118] the stent and its covering can be attached via a suitable adhesive). Mangiardi and Armstrong are involved in the same field of endeavor, namely medical devices. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the medical device of Mangiardi so that the surrounding membrane includes both a degradable and non-degradable component as is taught by Armstrong since this is a known alternative in the art to an entirely degradable membrane (Armstrong [0059]) and acts to provide plaque stabilization and scaffolding (Armstrong [0060]). Both degradable and non-degradable materials are well-used and understood alternatives in the art which are not recognized as being patentably distinct from one another. The Examiner points out that the goal of Mangiardi is simply to catch degradation products of the underlying degradable filament, and thus the amount of time the membrane is present would not affect any essential goal of Mangiardi. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to attach Mangiardi’s scaffold and membrane together via an adhesive coupling as is taught by Armstrong in order to provide a tie layer to ensure the filament and membrane stay adequately attached/connected as is desired.
The Examiner further respectfully notes additionally that the Mangiardi Armstrong Combination, with the membrane including first and second structural components is described as being its own “scaffold” ([0059], multiple coverings on the interior or exterior of the stent or both; [0060] the cover material forms a lattice with a plurality of openings; [0113]-[0114] the multiple layers of coating lattice can have multiple layers bonded together with openings offset or staggered, be imbibed, etc.; [0118]-[0120] the coating is a cover attached to the underlying stent adhesively, mechanically, or via extrusion, etc.).
Regarding claim 2 the Mangiardi Armstrong Combination teaches the medical device of claim 1 substantially as is claimed,
wherein further discloses the filament is absorbable and configured to degrade over time ([0061] degradable inner core).
Regarding claim 4 the Mangiardi Armstrong Combination teaches the medical device of claim 1 substantially as is claimed,
wherein the Combination further teaches the membrane is configured to promote tissue ingrowth onto the membrane, tissue attachment onto the membrane, or tissue encapsulation of the membrane (this is a functional limitation of the membrane (see explanation in the rejection to claim 1 above). See also Mangiardi [0050]; Armstrong [0114]).
Regarding claim 8 the Mangiardi Armstrong Combination teaches the medical device of claim 1 substantially as is claimed,
wherein Mangiardi further discloses the filament includes a cross-section that is at least one of uneven, jagged, star-like, and polygonal (see, for example Figure 3b in which the cross-section of the device is elliptical or oval. This is understood to be “uneven” (i.e. “not uniform” or “unequal”)). Alternatively the person of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the cross-section of the filament to be uneven: it has been held by the courts that a change in shape or configuration, without any criticality in operation of the device, is nothing more than one of numerous shapes that one of ordinary skill in the art will find obvious to provide based on the suitability for the intended final application. See MPEP 2144.04 (IV)(B). It appears that the disclosed device would perform equally well shaped as disclosed by Mangiardi.
Regarding claim 23 the Mangiardi Armstrong Combination teaches the medical device of claim 1 substantially as is claimed,
wherein Armstrong further teaches the membrane is “imbibed” ([0114]).
Regarding claim 27 the Mangiardi Armstrong Combination teaches the medical device of claim 1 substantially as is claimed,
wherein Armstrong further teaches the first and second structural components define a porosity ([0114] ePTFE is inherently porous; any degradable polymer agent will inherently have some level of porosity as soon as it begins to degrade).
Regarding claim 15 Mangiardi discloses an implantable medical device (abstract) comprising:
a structural element (Figure 1) formed by one or more absorbable filaments (Figure 2a item 21), the one or more filaments being configured to degrade over time into a plurality of fragments following implantation (This is stated as a “functional limitation” of the filaments (see explanation in the rejection to claim 1 above). See also Mangiardi’s abstract: the filaments are made of degradable metal), the plurality of fragments including one or more fragments of a first minimum size (this is considered to be inherent); and
a sheath element (Figure 2a item 23) at least partially covering the structural element (Figure 2a), the sheath element including a membrane ([0060] a thin biodegradable polymer coating is understood to be a membrane) and being configured to capture and retain the one or more fragments of the first minimum size during degradation of the one or more filaments (this is stated as a functional limitation of the membrane (see explanation in the rejection to claim 1 above). Since Mangiardi discloses all the structural features which would be required to perform the functional language, they anticipate the claimed apparatus.), and the membrane including a scaffold structure (Applicant’s specification has defined this as being “woven, knitted, non-woven, absorbable, or non-absorbable” ([00082]). Since the membrane 23 is woven or non-woven, it meets the limitation),
but is silent with regards to the membrane’s scaffold structure being formed in part by ePTFE defining a porous microstructure, and including a first, degradable structural component and a second, non-degradable structural component,
and an adhesive for coupling the membrane to the filament.
However, regarding claim 15 see the rejection/modification in the rejection to claim 1 above.
Claim(s) 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mangiardi in view of Armstrong as is applied above, further in view of Greenhalgh (US 20020052649 A1).
Regarding claim 28 the Mangiardi Armstrong Combination teaches the medical device of claim 1 substantially as is claimed,
wherein Mangiardi further teaches the membrane is porous ([0061] coating 23 is porous), and
wherein Armstrong also teaches the membrane is porous ([0114] porous ePTFE),.
While neither reference mentions whether or not the porous membrane is “configured for tissue ingrowth”, the Examiner points out this is a functional limitation of the claim. See the explanation above regarding “functional limitations”. In this case, the Examiner understands that all pores are not sized appropriately to allow tissue ingrowth, as cells have a certain size. Since Armstrong teaches the membrane is porous ePTFE ([0114]), and Greenhalgh, who is in the same field of endeavor of ePTFE medical devices, teaches that porous ePTFE can be sized appropriately to allow tissue ingrowth ([0031]), the person of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the Combination so that the membrane allowed tissue ingrowth as is taught by Greenhalgh in order to ensure the device is securely attached to the tissue of the patient before encapsulation of the underlying metal filament begins (Mangiardi [0087]), thus ensuring a secure biological attachment, reducing the probability of migration before encapsulation, and increasing patient safety and accuracy of implantation.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jacqueline Woznicki whose telephone number is (571)270-5603. The examiner can normally be reached M-Th 10am-6pm EST.
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/Jacqueline Woznicki/Primary Examiner, Art Unit 3774 06/03/26
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