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 . Please see the note below regarding the priority date of the instant application.
Priority
The instant invention has a priority date of 01/20/2023 since this is the first date the disclosure includes the subject matter of the first material (of the outer layer) having an ultimate tensile strength of greater than about 4 MPa, the first material (of the outer layer) having a density of about 0.2 to about 0.8 mg/mm3, and the second material (of the inner layer) having a density of about 1.0 to about 2 mg/mm3. Applications previous to this application in the chain only discuss the yield strength, ultimate tensile strength, and densities of the conduit as opposed to the inner/outer layer specifically.
Due to the Applicant’s newly added subject matter in this application that was not previously presented in the priority chain, this case is being examined under the provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 03/23/26 has been entered.
Response to Arguments
Applicant's arguments filed 03/23/26 have been fully considered but they are not persuasive.
On pages 5-6 regarding the priority of the claims, Applicant argues amendments have support to 03/07/2014.
The Examiner respectfully disagrees, noting the cited paragraphs [0008] and [0055] of the PCT parent fail to mention anything about the ultimate tensile strength of anything other than the conduit as a whole, which makes this argument unpersuasive. Similarly, [0038] absolutely does include density ranges, but these density ranges are described for a material present in the conduit as a whole, as opposed to specific layers of the conduit, which makes this unpersuasive.
On page 7 regarding 112a enablement rejections, Applicant argues amendments overcome the rejections of record, arguing the person of ordinary skill understands that the claimed features are “well-characterized” and “predictable ranges” for ePTFE.
The Examiner respectfully disagrees, noting the amendments which indicate these values are for ePTFE are new matter. There is no support in the originally filed claims for either specific material making up either specific inner/outer layer in the conduit to be ePTFE. See the rejection below.
On page 8 regarding prior art rejections, Applicant argues Bernstein and Tsuchikura are not eligible as prior art due to the Applicant’s priority to 03/07/2014.
The Examiner respectfully disagrees, noting that Applicant has not proven the parent applications have support for the subject matter described above in the “Priority” section, meaning the filing date of the instant invention remains 01/20/2023.
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.
Claims 1-2 and 5-6 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Claim 1 is rejected for not being enabled for the fluoropolymer conduit having a radial expandability from 20-200% above an initial conduit radius, the first material (the material of the outer layer) having a yield strength of about 0.01 MPa to about 4 MPa, and the first material (the material of the outer layer) having an ultimate tensile strength of greater than about 4 MPa.
Claim 5 is rejected for not being enabled for the conduit having a suture retention strength greater than or about equal to 0.5 N.
Remaining claims are rejected for depending on a non-enabled claim.
Addressing now the Wands factors:
Addressing now the "Wands" factors (MPEP 2164.01 (a)).
(A) The breadth of the claims: The claims are wide in scope as they are drawn towards any “implantable device” which can go into a human or animal.
(E) The level of predictability in the art: The level of predictability in the art is low, since it requires experimentation of manufacturing techniques, polymers science including pre-treatment and post-treatment options for polymers and other materials, the inclusion of other structures (e.g. stents, valves, extra layers), variables relating to the compressibility/expandability and deliverability of the implant, biocompatibility factors, safety and effectiveness barriers, and mechanical requirements for treatment including optimal stress, straight, strength, and elasticity for the implant.
(F), (G), and (H) The amount of direction provided by the inventor,
existence of working examples, and quantity of experimentation needed to make/use the invention based on the content of the disclosure: The Applicant generically states throughout the specification that the conduit can just “have” various mechanical properties. For example, [0031]-[0032] states that the conduit as a whole can have a yield strength of about 0.004 MPa to about 4 MPa, although no specific examples of materials or their processing/manufacturing techniques are provided as is discussed as being possible within the conduit (e.g. such as whether there is one material only ([0037], or combinations of materials ([0037]) and if so, how many materials are combined, whether/which of these materials has an internode distance ([0037]), what specific density the material(s) may have ([0038]), whether pre-treatment via heating is done on any of the material(s) ([0040]), whether additional material is added during pre-treatment ([0040]), whether the materials of the conduit are the same or different ([0041]), whether there are more than one layer of each of any specific material ([0042]), whether the conduit’s outer layer is degradable ([0042]), whether the conduit’s outer layer is frangible ([0043]), whether the mechanical properties of the conduit are consistent overall or whether these vary over the length ([0044]) or direction (0047]) and how these might affect the ultimate tensile strength, yield strength, and elongation of the conduit), no guidance as regards the specific layers or extra features of the conduit are discussed (e.g. such as a coating ([0039]), stent as being attached to or encapsulated by the conduit, or the inner layer of the conduit including the stent ([0048]), woven materials ([0048]), or valves ([0049], no matter their material ([0054]))), and no specific mechanical properties of the device itself have been suggested that would allow this yield strength of the conduit as a whole as suggested (e.g. such as a specific geometry ([0045]), or shape ([0046])). Notably, there isn’t even any mention of any specific polymer or even fluoropolymer here. While [0037] states that the conduit can include fluoropolymer materials such as including PTFE, ePTFE, polyester, PET, PDMS, PU, and or combinations thereof, the amount of experimentation even just between those specifically listed polymers and all the manufacturing/processing options, size/shape options, extra inclusions, and other manipulations mentioned throughout the specification would be exceptionally high.
Similarly, the specification [0033] states that the conduit as a whole can have an ultimate tensile strength that is 1 MPa greater than its yield strength (which, in referring back to [0031] and [0032] indicates the ultimate tensile strength actually is disclosed as ranging from about 1.004 MPa to about 5 MPa, and [0033] indicates the ultimate tensile strength can actually be greater than about 5 MPa. The amount of experimentation, in taking into account all the extra factors the disclosure includes as far as materials, processing, manufacturing, geometry, extra features, etc. simply adds to the exponentially growing list of factors the person of ordinary skill would have to experiment with in order to understand how to make/recreate/use this invention.
Similarly, in relation to claim 5, the specification indicates that the suture retention strength of the conduit as a whole depend on the yield strength and ultimate tensile strengths ([0034]), and accordingly, the person of ordinary skill now must additionally be required to experiment with materials, manufacturing techniques, processing techniques, additional included elements, sizes, shapes, etc., but now must also experiment to find the ultimate tensile strength, yield strength, and now suture retention strength of this conduit. The amount of experimentation for achieving this is much too great to be expected for a person of ordinary skill, even with their advanced knowledge requirements.
Moving on to the radial expandability of the conduit, the specification [0035] states that the expandability can be “about 20% to about 200% above its initial pre-expansion radius” but again includes millions (if not more) of permutations of possible materials and combinations of materials, whether they are woven, plastically deformable, frangible, degradable, how many layers there are and how thick each layer may be, what processing techniques each layer has, whether there are pre-treatment or post-treatments applied to any of the (combinations of) materials or other elements that might be included, how many other elements might be included that might affect the expandability of the conduit (e.g. the valve lying therein, or a stent in one of the layers), what properties, characteristics, materials, processing or manufacturing techniques, dimensions, etc. these other included elements themselves might have, etc. Without including any of this information, the person of ordinary skill is unable to determine by experiment, how to make/recreate/use the claimed invention.
Additional factors that must be factored into the exceptional amount of experimentation is the conduit’s wide range in wall thickness ([0046]) and wide range in compressed diameters ([0046]).
Notably, the most specific examples Applicant includes are:
[0055]: the conduit includes a first and second layer, with a valve in the second layer. A first layer can be plastically deformable with yield strength of 0.1-4 MPa. The second layer can be made of same material as first OR different material, the first/second layers can be woven, the inner layer can be degradable or non-plastically deformable, or the conduit includes a stent in the second layer. (It can be seen that this lacks mention of all of the above permutations of combinations the disclosure requires one of ordinary skill to experiment with in order to make/use this invention.)
[0073]: One material that can be included somewhere in the conduit is plastically deformable, has an average yield strength of about 2.1 MPa, an ultimate tensile strength of about 5 MPa, an average elastic modulus of about 5.9 MPa, and a 36% elongation at the location where the material transitions from elastically to plastically deformable. (It can be seen that this also lacks all the mention of previously mentioned permutations and combinations of variables that the person of ordinary skill still has to experiment with.)
and [0074]: One material that can be included somewhere in the conduit is plastically deformable, has an yield strength of about 1.7 MPa, an ultimate tensile strength of about 5.5 MPa, an average elastic modulus of about 7.4 MPa, and a 24% elongation when it switches from elastically to plastically deformable. (Again, this also lacks all the mention of previously mentioned permutations and combinations of variables that the person of ordinary skill still has to experiment with.)
Overall, the disclosure does not provide enough direction or examples, and requires much too much experimentation in order to have a person of ordinary skill make/use the invention based on the content of the disclosure. The claims are accordingly not enabled.
Claims 1-2, 5-6 are 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(s) 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 is rejected for having new matter for claiming the inner layer comprises a second material comprising ePTFE and the outer layer comprises a first material comprising ePTFE. There is no support in the originally filed disclosure for the inner layer comprising a second material comprising ePTFE, or the outer layer comprising a first material comprising ePTFE. Paragraph [0005] states that ePTFE valved conduits are known in the art. Paragraph [0037] states that the conduit can comprise one or more materials, and one of those materials can comprise ePTFE. There is no other part of the disclosure which mentions ePTFE, particularly no place that mentions it being in one of two specific layers. While the disclosure does indicate there can be an inner layer and an outer layer of the conduit, there is no indication that ePTFE is or is not present in either specific layer of the conduit. This is accordingly considered new matter.
Further, the claim has new matter for claiming the second material (ePTFE), of the inner layer, has a density of about 1.0-2 mg/mm3 and the first material (ePTFE) of the outer layer, has a density of 0.2-0.8 mg/mm3. The specification [0038] indicates that material(s) of the conduit can have those specific densities, but there is no disclosure or support for the inner layer comprising a second material (that second material being ePTFE), the outer layer comprising a first material (that first material being ePTFE), or the first and second materials having the specific claimed densities. This is accordingly considered to be new matter.
Remaining claims are rejected for depending on a claim with new matter.
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.
Claims 1-2 and 5-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bernstein et al. (US 20160015516 A1) hereinafter known as Bernstein in view of Tsuchikura et al. (US 20180147044 A1) hereinafter known as Tsuchikura.
Regarding claim 1, Bernstein discloses an implantable device for implantation into a human or animal (Bernstein claim 1), the device comprising:
a fluoropolymer conduit (Bernstein claim 7) comprising ePTFE ([0037]), and having an inner layer ([0042]) and an outer layer ([0042]),
wherein the conduit has a radially expandability in a range from 20-200% above an initial conduit radius (Bernstein claim 4),
wherein the conduit has a density of about 0.2 mg/mm3 to about 2 mg/mm3 ([0038]), and the conduit has a density of about 1.0 mg/mm3 to about 2 mg/mm3 ([0038]),
and wherein the conduit comprises nodes having an internode distance of about 10 microns to about 40 microns ([0037]);
but is silent with regards the outer layer comprising a first material comprising ePTFE, the first material having a yield strength of about 0.01 to about 4 MPa and an ultimate tensile strength greater than about 4 MPa,
and the inner layer comprising a second material comprising ePTFE, wherein the second material of the inner layer has a density of about 1.0mg/mm3 to about 2 mg/mm3.
However, regarding claim 1 Bernstein teaches their conduit can comprise a first and/or second material comprising ePTFE ([0037]), and that their conduit can comprise an inner layer and an outer layer ([0043]). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the conduit of Bernstein so that the inner and outer layers comprise ePTFE since Bernstein teaches this is a suitable material for the conduit as a whole, and there can be an inner and outer layer ([0037], [0043]). Further, regarding claim 1 Bernstein teaches that their conduit can include a yield strength of about 0.1 to 4 Mpa (Bernstein claim 1), and the conduit can include an ultimate tensile strength of greater than about 4 MPa ([0033]). While being silent with regards to the properties of the first material of the outer layer itself, the person of ordinary skill at the time the invention was filed would have found it obvious for the first material of the conduit to include properties of the conduit as a whole.
Further, regarding claim 1 Tsuchikura teaches that an inner layer of an implantable fluoropolymer conduit can have a greater density than an outer layer of the conduit (Table 1). Bernstein and Tsuchikura are involved in the same field of endeavor, namely implantable devices. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the device of Bernstein so that the inner layer is denser than the outer layer as is taught by Tsuchikura in order to ensure the inner layer is less permeable to fluids it may be carrying, while balancing a less dense outer layer to give the construct thickness and ideal flexibility. Since Bernstein already teaches the range of densities for the conduit ([0038]), the person of ordinary skill in the art would have likewise found it obvious for the outer layer to have density falling within the density range of the conduit as a whole (and be less than the density of the inner layer as is taught by Tsuchikura) and for the inner layer falling within the range of the conduit as a whole (and be more than the density of the outer layer as is taught by Tsuchikura).
Regarding claim 2, the Bernstein Tsuchikura Combination teaches the device of claim 1 substantially as is claimed,
wherein Bernstein further discloses the conduit has a wall thickness of about 0.2 mm to about 2.0 mm ([0046]), but is silent with regards to the thickness of the outer layer.
However, regarding claim 2 the person of ordinary skill in the art at the time the invention was filed would have found it obvious for the outer layer to have a wall thickness of, for example, about 1 mm (which falls within the claimed range) since Bernstein teaches both the inclusion of an inner and outer layer ([0042]). The person of ordinary skill would understand that either layer could comprise layers of varying thickness which make up part of the thickness of the conduit as a whole.
Regarding claim 5, the Bernstein Tsuchikura Combination teaches the device of claim 1 substantially as is claimed,
wherein Bernstein further discloses the conduit is configured to be implanted into a cardiovascular structure using sutures, and wherein the conduit has a suture retention strength greater than or about equal to 0.5 N ([0034]).
Regarding claim 6, the Bernstein Tsuchikura Combination teaches the device of claim 1 substantially as is claimed,
wherein Bernstein further discloses the conduit further comprises a valve structure (Bernstein claim 9).
Conclusion
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jerrah Edwards can be reached on 408-918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Jacqueline Woznicki/Primary Examiner, Art Unit 3774 04/23/26
Prosecution Insights