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 .
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-10, drawn to a stent, classified in A61F2/86.
II. Claims 11-15, drawn to a method of manufacturing a stent, classified in B33Y80/00.
III. Claims 16-20, drawn to a method of stenting a vessel, classified in A61B17/12118.
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as process of making and product made. The inventions are distinct if either or both of the following can be shown: (1) that the process as claimed can be used to make another and materially different product or (2) that the product as claimed can be made by another and materially different process (MPEP § 806.05(f)). In the instant case the stent can be manufactured by a different process, such as laser cutting and coating.
Inventions I and III are related as process and apparatus for its practice. The inventions are distinct if it can be shown that either: (1) the process as claimed can be practiced by another and materially different apparatus or by hand, or (2) the apparatus as claimed can be used to practice another and materially different process. (MPEP § 806.05(e)). In this case, the apparatus can be used in a materially different process such as for being used as shunt to redirect blood flow.
Inventions II and III are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case, the process of using the product can be used with another materially different product, such as a tube formed of a woven material can be used to stent a vessel.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
The inventions have acquired a separate status in the art in view of their classification;
The inventions require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries).
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
During a telephone conversation with Keith Baxter on 5/26/26 a provisional election was made without traverse to prosecute the invention of Group I, claims 1-10. Affirmation of this election must be made by applicant in replying to this Office action. Claims 11-20 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
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.
Claims 1-4, 6-10 are rejected under 35 U.S.C. 103 as being unpatentable over Moss (US2013/0190848) in view of Ramzipoor (US2023/0414385)
Regarding claim 1, Moss discloses a stent (303) comprising:
a tube (tube defined by the stent) defined by a piezoelectric substrate (coating or covering material that generates an electric field, [0034], where the material is a piezoelectric material, [0030]) material formed in a pattern permitting compression and expansion of the tube (the material of the layers of the stent deforms by internal pressure changes due to blood flow and cause a buildup in the piezoelectric structure and result in an electric field, [0034]);
wherein the piezoelectric substrate is poled with respect to at least one axis of the tube (negative charge distribution about the internal medical device, [0021]; where the device is poled to along the same axis to generate an electric field, [0021]); and
wherein the piezoelectric substrate generates a voltage of at least 10 mV under pressure changes on an inside or outside of the tube to create an electric field surrounding the tube ([0023], [0057]).
Moss does not disclose the tube formed in a cylindrical lattice pattern. Ramzipoor teaches a stent 100 comprising a plurality of rings in a zig-zag pattern along a circumference of the ring, with the ring interconnected by struts 104 ([0045]) (where the cross of the ringed zig-zag pattern with the struts would make a lattice pattern and the form of a stent is cylindrical). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the tube of Moss to be formed in a cylindrical lattice pattern as taught by Ramzipoor in order to have the stent have a higher degree of malleability to expand, deform, and maintain its position securely within the vessel ([0004]).
Regarding claim 2, Moss/Ramzipoor makes obvious the stent of claim 1, Moss further discloses wherein the piezoelectric substrate generates a voltage output of 10-150 mV ([0023], [0057]).
Regarding claim 3, Moss/Ramzipoor makes obvious the stent of claim 1, Moss further discloses wherein the piezoelectric substrate generates a voltage output of at least 10 mV ([0023], 0057]) under pressure changes of at least 40 mmHg on an inside or outside of the tube (pressure changes in vessels near the heart are normally greater than 40 mmHg; where the device of Moss is near the heart, [0023]).
Regarding claim 4, Moss/Ramzipoor makes obvious the stent of claim 1, Moss further discloses wherein the electric field is less than 12 V/cm ([0025]).
Regarding claim 6, Moss/Ramzipoor makes obvious the stent of claim 1, Moss further discloses wherein the substrate is poled in an axial direction of the tube (negative charge distribution about the internal medical device which would be along the axial direction, [0021]; where the device is poled to along the same axis to generate an electric field, [0021]).
Regarding claim 7, Moss/Ramzipoor makes obvious the stent of claim 1, Moss further discloses the tube being can be used for places around the heart ([0055]); yet, does not explicitly disclose wherein the tube has a uniform thickness of less than or equal to 250 um. Ramzipoor further teaches, the reach of the rings have a thickness of 40 um to 50 um ([0049]); and would therefore define a uniform thickness by having the same thicknesses. 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 tube of Moss/Ramzipoor to have a uniform thickness of less than or equal to 250 um as taught by Ramzipoor in order to provide a low profile device that can minimize the formation of blood thrombi ([0049]).
Regarding claim 8, Moss/Ramzipoor makes obvious the stent of claim 1, Moss further discloses the tube being can be used for places around the heart ([0055]); yet, does not explicitly disclose wherein the tube has a diameter between 2 to 50 mm. Ramzipoor teaches the stent having a diameter in the range of 2.9 mm to 3.7 mm by the expansion of a balloon ([0101]). 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 tube of Moss/Ramzipoor to have a diameter between 2 to 50 mm, as applicant appears to have placed no criticality on the claimed range (see [0019], indicating the tube may have a diameter within the claimed range) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claim 9, Moss/Ramzipoor makes obvious the stent of claim 1, Moss further discloses the tube being can be used for places around the heart and the piezoelectric material is a layer and therefore would be of a similar length to the tube ([0055]); yet, is silent regarding wherein the piezoelectric substrate has a length between 2 to 200 mm. 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 piezoelectric substrate of Moss/Ramzipoor to have a length between 2 to 200 mm, as applicant appears to have placed no criticality on the claimed range (see [0019], indicating the piezoelectric substate may have a length within the claimed range) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claim 10, Moss/Ramzipoor makes obvious the stent of claim 1, Ramzipoor further teaches wherein the cylindrical lattice pattern is zigzag rings formed about the axis of the tube joined by bridges (rings are in zig-zag pattern connected with struts/bridges, [0045]).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Moss (US2013/0190848) in view of Ramzipoor (US2023/0414385) as applied to claim 1, and further in view of Deng (US2020/0261621).
Regarding claim 5, Moss/Ramzipoor makes obvious the stent of claim 1, Moss further discloses a ferroelectric polymer being polyvinylidene fluoride ([0030]); yet, does not explicitly disclose wherein the piezoelectric substrate is made of ferroelectric potassium sodium niobite (KNN) particles embedded in a ferroelectric polyvinylidene fluoride (PVDF) polymer matrix. Deng teaches an electrified composite membrane (see Abstract), the membrane having a matrix made of PVDF ([0007]) with fiber filings (particles) of KNN ([0007]). It would have been obvious to one having ordinary skill in the art before the filing date of the claimed invention to have substituted the piezoelectric substrate of Deng for the piezoelectric substrate of Moss/Ramzipoor since the substitution would have yielded the same predictable result of a material with ferroelectric properties for application to a medical implant.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MIKAIL A MANNAN whose telephone number is (571)270-1879. The examiner can normally be reached M-F 10-6.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Barrett can be reached at (571)272-4746. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.A.M/Examiner, Art Unit 3774
/THOMAS C BARRETT/SPE, Art Unit 3799
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