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 .
DETAILED ACTION
Acknowledgement is made of applicant’s amendment which was received by the office on July 14, 2026. Claims 1-3,5 and 7-18 are currently pending and under examination.
Specification
The disclosure is objected to because of the following informalities: Applicant has made amendments to the specification and has provided a clean copy of the specification but has not provided a separate marked up version showing the changes in the specification relative to the previous version in accordance with 37 CFR 1.125, see MPEP 714. Appropriate correction is required.
Drawings
In view of the response filed 7/14/2026 amending the specification to remove reference numerals #3a,3b the objections made against the drawings in the office action of 4/8/2026 have been withdrawn.
Claim Objections
Claims 1-3,5 and 7-18 are objected to because of the following informalities: Claim 1, line 6 should recite similar to –comprised between two of said set of electrodes—in order to provide proper antecedent basis. Appropriate correction is required. Claims 2-3,5 and 7-18 directly or indirectly depend from claim 1 and are also objected to for the reasons stated above regarding claim 1.
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 1-3,5,7-18 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 1 has been amended to recite “wherein said tubular counterpulsation device has at least a first level of modified visco- elasticity associated to a first level of voltage supplied to said at least one layer of stretchable polymer through the electrodes, said first level of modified visco-elasticity exerting a first modified force directed toward the inner space of the tubular device when the diameter thereof is extended by the expending force of the flowing blood to a diameter larger than the native diameter thereof, the first modified force being lower than the natural force so that the resistance to the expanding force of the flowing blood decreases and that the diameter of the tubular device increases to a first modified diameter higher than the diameter obtained without application of the first level of voltage.” It is unclear what structural features of the tubular counterpulsation device applicant is attempting to encompass when reciting “wherein said tubular counterpulsation device has at least a first level of modified visco- elasticity associated to a first level of voltage supplied to said at least one layer of stretchable polymer through the electrodes, said first level of modified visco-elasticity exerting a first modified force directed toward the inner space of the tubular device when the diameter thereof is extended by the expending force of the flowing blood to a diameter larger than the native diameter thereof, the first modified force being lower than the natural force so that the resistance to the expanding force of the flowing blood decreases and that the diameter of the tubular device increases to a first modified diameter higher than the diameter obtained without application of the first level of voltage.” since the claim recites a result that is achieved without the particulars of the structure required to achieve the result. It appears that applicant is concerned with a visco-elasticity exerting a force towards an inner space of the tubular counterpulsation device when the diameter of the tubular device is extended by an expending force of flowing blood but it is unclear what structural limitations of the tubular device applicant is attempting to encompass. Is applicant stating that the layer of stretchable polymer is a material that has at least a first level of modified visco- elasticity associated to a first level of voltage supplied to said at least one layer of stretchable polymer through the electrodes, said first level of modified visco-elasticity exerting a first modified force directed toward the inner space of the tubular device that is lower than a natural force when blood flows through the tube? If so, what particular material or structural features of the layer of stretchable polymer is applicant attempting to encompass when reciting the limitations above? Clarification is required. Claims 2-3,5 and 7-18 directly or indirectly depend from claim 1 and are also rejected to for the reasons stated above regarding claim 1. Regarding claim 1, as best understood, the claim has been interpreted to include devices that includes a power supply, a set of electrodes and a layer of polymer that is made with silicone between two electrodes. Regarding claim 14, as best understood, the claim is related to a method that includes stacking layers and then rolling those layers into a tube, see claim rejections below.
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) 1,7,9 and 11-12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2016/0144091 to Breedon et al. (Breedon) (previously cited).
In reference to at least claim 1
Breedon discloses a stretchable counterpulsation tubular device (e.g. fluid pump device 10 is stretchable) adapted for passively mimic the natural properties of an artery through which blood flows (e.g. flexible support structure 12, para. [0078], passive DEA membrane, para. [0103]), comprising a power supply (e.g. power from the implanted battery with terminals 18a,18b, para. [0077]) and a set of electrodes (e.g. “compliant electrode layers” of the “dielectric elastomeric actuator structure”, para. [0078]) connected to said power supply (e.g. connections 17a,17b are connected to terminals 18a,18b, para. [0079]), and at least one layer of a stretchable polymer (e.g. polymeric materials, para. [0058]), said at least one layer of polymer being made with silicone and comprised between two electrodes (e.g. dielectric elastomer materials can include silicone elastomers, para. [0056]), wherein the power supply is adapted to supply at least a first level of voltage to said electrodes (e.g. “applying a voltage”, para. [0080]), wherein said tubular counterpulsation device has a native diameter and an inherent visco- elasticity exerting a natural force directed toward inner space of said tubular counterpulsation device when the diameter thereof is extended by the expending force of the flowing blood to a diameter larger than the native diameter thereof (e.g. “expanding by returning to its relaxed form”, para. [0080]), and in that the said counterpulsation device has at least a first level of modified visco-elasticity when a first level of voltage is supplied to the layers of stretchable polymer through the electrodes (e.g. applying a voltage inherently provides a first level of visco-elasticity, para. [0080]). Breedon which discloses all of the structural features of claim 1 would be at least capable of performing the functions of “at least a first level of modified visco- elasticity associated to a first level of voltage supplied to said at least one layer of stretchable polymer through the electrodes, said first level of modified visco-elasticity exerting a first modified force directed toward the inner space of the tubular device when the diameter thereof is extended by the expending force of the flowing blood to a diameter larger than the native diameter thereof, the first modified force being lower than the natural force, so that the resistance to the expanding force of the flowing blood decreases and that the diameter of the tubular device increases to a first modified diameter higher than the diameter obtained without application of the first level of voltage.”
In reference to at least claim 7
Breedon discloses wherein the number of layers is comprised between 2 and 50, forming a stack of layers, wherein each of the layers is comprised between two electrodes (e.g. stack of layers comprised between electrodes, Figs. 2a-2b, para. [0080]).
In reference to at least claim 9
Breedon discloses the tubular device being adapted to surround or replace a portion of a tubular structure such as an artery (e.g. surrounding the aorta, Figs. 1c,1d).
In reference to at least claim 11
Breedon discloses the tubular device comprising a shielding layer (e.g. electromagnetic shielding layers, para. [0027]).
In reference to at least claim 12
Breedon discloses a control unit connected to the power supply adapted to apply a given level of voltage at determined times and for determined periods of time and/or by intermittence (e.g. electronic controller configured to apply the actuation voltage at determined times, para. [0026]).
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.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2016/0144091 to Breedon et al. (Breedon) in view of US 2012/0053672 to Gharib et al. (Gharib) (previously cited).
In reference to at least claim 13
Breedon discloses a stretchable counterpulsation tubular device according to claim 1, see above, but does not explicitly teach a kit with a first and second stretchable tubular device with different natural and modified forces. It was well-known in the art before the effective filing date of the claimed invention to provide kits that include several tubular counterpulsation devices, a control module and other elements needed for implantation as evidence by Gharib (e.g. para. [0012], [0041]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Breedon to include a kit with several counterpulsation tubular devices, power supply, control module, sensors, delivery device, appropriate instructions in order to provide an all in one place for all the elements needed for implantation.
Claim(s) 14-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2016/0144091 to Breedon et al. (Breedon) in view of US 2021/0361929 to Chavanne et al. (Chavanne) (previously cited).
In reference to at least claim 14
Breedon discloses a process for producing the stretchable counterpulsation tubular device as defined in claim 1 adapted for passively mimic the natural properties of an artery through which blood flows (e.g. flexible support structure 12, para. [0078], passive DEA membrane, para. [0103]), comprising step sequence of producing several combinations of a stretchable layers and a conductive layer (e.g. Fig. 7, “A first layer of conductive ink is deposited on the surface of the balloon (step 72). The conductive ink may alternatively be deposited after first inflating the balloon, to ensure continuity of the electrode layer deposited, followed by deflation before the next step. A layer of electroactive polymer material is then applied (step 73), following which, after the layer is set, the balloon is inflated (step 74). A further layer of conductive ink is then applied over the electroactive material layer (step 76), optionally after scanning the surface of the inflated balloon to determine its shape (step 75, described above in relation to FIG. 3). If a further layer is required (step 77), the balloon is deflated (step 78) and the process is then repeated. Once a required number of successive electroactive layers have been deposited, a support structure layer is deposited (step 79). The whole process may then be repeated again, if further layers of electroactive material and support structure layers are required (step 80),” para. [0108]), and stacking said combinations so as to alternated the stretchable layers and conductive layers, resulting a final stack of stretchable layers (e.g. “A layer of electroactive polymer material is then applied (step 73), following which, after the layer is set, the balloon is inflated (step 74). A further layer of conductive ink is then applied over the electroactive material layer (step 76), optionally after scanning the surface of the inflated balloon to determine its shape (step 75, described above in relation to FIG. 3). If a further layer is required (step 77), the balloon is deflated (step 78) and the process is then repeated. Once a required number of successive electroactive layers have been deposited, a support structure layer is deposited (step 79). The whole process may then be repeated again, if further layers of electroactive material and support structure layers are required (step 80),” para. [0108]). Breedon discloses that the diameter of said tubular shape of final stack of stretchable layers is adapted to vary under the pressure variation of the blood pressure (e.g. flexible support structure 12 capable of varying under variation of the blood pressure, para. [0078], passive DEA membrane, para. [0103]).
However, Breedon does not explicitly teach rolling said final stack of stretchable layers around a tube to produce a tubular shape.
Chavanne discloses a plurality of elements and actuator that includes a stack comprising a plurality of layers (e.g. Figs. 1A-1B, “at least one layer”, para. [0032]) in which the electrode film is rolled into a cylinder and electrodes provide on an inside and outside of the cylinder (e.g. para. [0053]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the process of Breedon to include rolling said final stack of stretchable layers around a tube to produce a tubular shape, as taught by Chavanne, in order to produce the desired tubular shape to aid in pumping of fluid inside the vessel and/or assistance of displacement of liquid inside the vessel (‘929, para. [0071]).
In reference to at least claim 15
Breedon modified by Chavanne renders obvious the method of claim 14. Breedon further discloses a step of coating the obtained tubular shape with a conductive material to provide a shielding layer (e.g. electromagnetic shielding layers, para. [0027]).
Response to Arguments
Claim Rejection – Indefiniteness
Applicant's arguments filed 7/14/2026 have been fully considered but they are not persuasive. Applicant argues that the material and structural features allowing to modify the viscoelastic properties of polymers are provided, see pg. 7 of response filed 7/14/2026. This is not persuasive. Applicant has amended claim 1 to include a silicone between two of said electrodes. Applicant has not clarified what structural features of the tubular counterpulsation device applicant is attempting to encompass when reciting “wherein said tubular counterpulsation device has at least a first level of modified visco- elasticity associated to a first level of voltage supplied to said at least one layer of stretchable polymer through the electrodes, said first level of modified visco-elasticity exerting a first modified force directed toward the inner space of the tubular device when the diameter thereof is extended by the expending force of the flowing blood to a diameter larger than the native diameter thereof, the first modified force being lower than the natural force so that the resistance to the expanding force of the flowing blood decreases and that the diameter of the tubular device increases to a first modified diameter higher than the diameter obtained without application of the first level of voltage.” since the claim recites a result that is achieved without the particulars of the structure required to achieve the result. It appears that applicant is concerned with a visco-elasticity exerting a force towards an inner space of the tubular counterpulsation device when the diameter of the tubular device is extended by an expending force of flowing blood but it is unclear what structural limitations of the tubular device applicant is attempting to encompass. Is applicant stating that the layer of stretchable polymer is a material that has at least a first level of modified visco- elasticity associated to a first level of voltage supplied to said at least one layer of stretchable polymer through the electrodes, said first level of modified visco-elasticity exerting a first modified force directed toward the inner space of the tubular device that is lower than a natural force when blood flows through the tube? If so, what particular material or structural features of the layer of stretchable polymer is applicant attempting to encompass when reciting the limitations above? As discussed above, applicant has amended claim 1 to include a silicone between two of said electrodes. If applicant intends the claim to encompass any silicone that is comprised between two electrodes as being capable of providing the functions recited within claim 1 such statement should be made of record to aid in determining the metes and bounds of the claim limitations. It is noted that the above interpretation has been used for the purposes of examination as best understood.
Claim Rejection – Prior Art
Applicant's arguments filed 7/14/2026 have been fully considered but they are not persuasive. Applicant argues that Breedon fails to provide any intermediate stacks of layers, which are then combined to the previous stacks of layers, see pg. 7-8 of response filed 7/14/2026. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “stacks of layers are combined to each others. In step S1 [0038], "The combination of the first layer L1 and the conductive layer Lc, and possibly the first support layer Lz forms a stack" and in the next step "A new stack of layers is organized according to step Si and then placed up-side down on the newly added conductive layer La2", see pg. 7-8 of response filed 7/14/2026) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Applicant argues that Breedon fails to disclose "step sequence of producing several combinations of a stretchable layers and a conductive layer, and stacking said combinations so as to alternated the stretchable layers and conductive layers", see pg. 8 of response filed 7/14/2026. This is not persuasive. Breedon discloses “A first layer of conductive ink is deposited on the surface of the balloon (step 72). The conductive ink may alternatively be deposited after first inflating the balloon, to ensure continuity of the electrode layer deposited, followed by deflation before the next step. A layer of electroactive polymer material is then applied (step 73), following which, after the layer is set, the balloon is inflated (step 74). A further layer of conductive ink is then applied over the electroactive material layer (step 76), optionally after scanning the surface of the inflated balloon to determine its shape (step 75, described above in relation to FIG. 3). If a further layer is required (step 77), the balloon is deflated (step 78) and the process is then repeated. Once a required number of successive electroactive layers have been deposited, a support structure layer is deposited (step 79). The whole process may then be repeated again, if further layers of electroactive material and support structure layers are required (step 80), see Fig. 7 and para. [0108], therefore Breedon does disclose step sequence of producing several combinations of a stretchable layers and a conductive layer. Breedon further discloses “A layer of electroactive polymer material is then applied (step 73), following which, after the layer is set, the balloon is inflated (step 74). A further layer of conductive ink is then applied over the electroactive material layer (step 76), optionally after scanning the surface of the inflated balloon to determine its shape (step 75, described above in relation to FIG. 3). If a further layer is required (step 77), the balloon is deflated (step 78) and the process is then repeated. Once a required number of successive electroactive layers have been deposited, a support structure layer is deposited (step 79). The whole process may then be repeated again, if further layers of electroactive material and support structure layers are required (step 80),” see para. [0108], therefore Breedon does disclose stacking said combinations so as to alternated the stretchable layers and conductive layers, resulting a final stack of stretchable layers.
Applicant argues “Furthermore, Chavanne also fails to teach the step of "rolling said final stack of stretchable layers around a tube to produce a tubular shape". There is indeed no mention in Chavanne of any tube around which is rolled the stretchable structure., see pg. 8 of response filed 7/14/2026. This is not persuasive. Chavanne discloses with Figs. 1A-1B a stack comprising a plurality of layers and that the electrode film is rolled around a cylinder, i.e. tube, with electrodes provide on an inside and outside of the cylinder, see para. [0053].
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 JENNIFER L GHAND whose telephone number is (571)270-5844. The examiner can normally be reached Mon-Fri 7:30AM - 3:30PM ET.
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/JG/Examiner, Art Unit 3796
/REX R HOLMES/Primary Examiner, Art Unit 3796
