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
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/8/2025 has been entered. Claims 1-3 and 5-18 are currently pending and under examination.
Specification
The disclosure is objected to because of the following informalities: Applicant has indicated that the specification has been replaced with a substitute specification filed herewith, see pg. 2 of response filed 12/8/2025, however a substitute specification has not been filed, clarification is required. Appropriate correction is required.
Drawings
The drawings are objected to as failing to comply with PCT Rule 11 because they do not include the following reference sign(s) mentioned in the description: #3a,3b (para. [0015]). Corrected drawing sheets in compliance with PCT Rule 11 are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
In view of the amendment filed on 12/8/2025 amending claims 1,6,8,13 and 16 to clarify the language the objections made against the claims in the office action of 9/8/2025 have been withdrawn.
Claim Rejections - 35 USC § 112
In view of the amendment filed on 12/8/2025 amending claims 2 and 18 to clarify the language the 112(b) rejections made against claims 2 and 18 within the office action mailed 9/8/2025 have been withdrawn.
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 and 5-18 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 and 5-18 directly or indirectly depend from claim 1 and are also rejected to for the reasons stated above regarding claim 1. The 112 issues have made it difficult to determine the metes and bounds regarding the structural elements required of the tubular counterpulsation device of claims 1-3, 5-13 and 16-18 in order to perform a proper search of the prior art. 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 § 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) 14-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2016/0144091 to Breedon et al. (Breedon) (previously cited) in view of US 2021/0361929 to Chavanne et al. (Chavanne).
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 – Prior Art
Applicant’s arguments with respect to claims 1-3,5-7,9,11-12 as anticipated by Breedon and claims 1-3, 9-10, 12 and 16 as anticipated by Mower have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. As stated above, the 112 issues have made it difficult to determine the metes and bounds regarding the structural elements required of the tubular counterpulsation device of claims 1-3, 5-13 and 16-18 in order to perform a proper search of the prior art and to determine whether Breedon and Mower are still applicable.
Applicant’s arguments, see pgs. 7-8, filed 12/8/2025, with respect to the rejection(s) of claim(s) 14-15 as anticipated by Breedon have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of US 2021/0361929 to Chavanne et al., see claim rejections above.
Conclusion
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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/JENNIFER L GHAND/Examiner, Art Unit 3796
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