DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Objections
Claim 18 is objected to because of the following informalities: “The method of claim 16, wherein upon expansion, the expandable element one or more of expands the stent structure or delivers a drug or energy source” should be amended to - - The method of claim 16, wherein upon expansion, the expandable element . Appropriate correction is required.
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.
Claim 6 is 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 6 recites the limitation "the scaffold" in line 1. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, claim 6 is interpreted as reciting - - wherein the stent structure is electrically conductive and configured to transfer energy or electrical pulses to the vessel wall - - .
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Application claims 2- 5 and 7- 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1- 17 of U.S. Patent No. 12,268,410. Although the claims at issue are not identical, they are not patentably distinct from each other because
Application
U.S. Patent No. 12,268,410
Application claim 2
claim 1 of U.S. Patent No. 12,268,410:
Application claim 2 is obvious over claim 1 of U.S. Patent No. 12,268,410. It is noted Application claim 2 is broader than claim 1 of U.S. Patent No. 12,268,410 since “a plurality of notched scoring elements” recited in claim 1 of U.S. Patent No. 12,268,410 is a specific type of “a plurality of non-continuous scoring elements,” since a notch or gap is a break in continuity such that a scoring element is non-continuous.
Application claim 3
claim 2 of U.S. Patent No. 12,268,410
Application claim 4
claim 3 of U.S. Patent No. 12,268,410
Application claim 5
claim 4 of U.S. Patent No. 12,268,410
claim 5 of U.S. Patent No. 12,268,410
Application claim 6
Application claim 7
claim 6 of U.S. Patent No. 12,268,410
Application claim 8
claim 7 of U.S. Patent No. 12,268,410
Application claim 9
claim 14 of U.S. Patent No. 12,268,410
Application claim 10
claim 15 of U.S. Patent No. 12,268,410
Application claim 11
claim 16 of U.S. Patent No. 12,268,410
Application claim 12
claim 17 of U.S. Patent No. 12,268,410
Application claim 13
claim 8 of U.S. Patent No. 12,268,410
Application claim 14
claim 9 of U.S. Patent No. 12,268,410
Application claim 15
claim 10 of U.S. Patent No. 12,268,410
Application claim 16
claim 11 of U.S. Patent No. 12,268,410
Application claim 17
claim 12 of U.S. Patent No. 12,268,410
Application claim 18
claim 13 of U.S. Patent No. 12,268,410
Application claim 19
Application claim 6 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,268,410 in view of Miller (US Pub. No. 2003/0229370 A1).
Regarding application claim 6 in view of the rejection under 35 U.S.C. 112(b) above, Application claim 2 is obvious over claim 1 of U.S. Patent No. 12,268,410, but claim 1 of U.S. Patent No. 12,268,410 does not claim
(application claim 6) wherein the scaffold is electrically conductive and configured to transfer energy or electrical pulses to the vessel wall.
However, Miller teaches a method of treating a target site within a vascular lumen while diminishing injury to a vascular site in the same field of endeavor (Ps. [0030], [0046], [0047] - -the application of energy to the microscalpel cutting blades can further reduce the pressure required to incise a stenosis; the inventive cutting balloons and balloon catheters can be used to incise stenosis at lower dilatation pressures, or to incise stenosis that are difficult to incise utilizing conventional cutting balloons. As such, trauma to the vessel wall, as well as any subsequent restenosis that can result therefrom, can be reduced; the present invention further provides a method of dilating and incising a stenosis using the inventive balloon catheter, which method can generally be described with reference to FIG. 3)
(application claim 6) wherein the scaffold (350) (Fig. 3) is electrically conductive and configured to transfer energy or electrical pulses to the vessel wall (Ps. [0030], [0032], [0047] - - The provision of energy to the microscalpel blades can provide further advantages to the inventive cutting balloon and catheter. For example, the application of energy to the microscalpel cutting blades can further reduce the pressure required to incise a stenosis, i.e. beyond the reduction already provided by the enhanced sharpness of the microscalpels relative to conventional cutting elements. Advantageously, the energy provided to the microscalpel cutting blades may be controllable, so that the energy may be turned on, off, pulsed, or otherwise varied in type, strength, etc., further enhancing the control and precision that may be exercised over incising a stenosis using the inventive cutting balloon and catheter. Thus, the microscalpel blades are desirably and advantageously operatively disposed relative to a power source that supplies energy, such as thermal, RF, electric, or oscillatory energy, to the microscalpels; For exemplary purposes only then, one such configuration might have the power source provided as a component separate from the balloon catheter and connected to the microscalpels via one or more conductors capable of conducting or transmitting the energy provided by the power source. Any such conductor(s) may be connected directly to the microscalpel blades, or may be operatively disposed to a transducer that is in turn operatively disposed relative to the microscalpel blades. If the conductor(s) are desirably connected directly to the microscalpels, the conductors themselves are desirably operatively disposed relative to a transducer; In this regard, the present invention further provides a method of dilating and incising a stenosis using the inventive balloon catheter, which method can generally be described with reference to FIG. 3 … If desired, during any portion of the inflation or any other period that any portion of microscalpel 320 is disposed within stenosis 362 so as to be capable of incising stenosis 362, microscalpel 320 may be activated with ultrasonic energy as provide to microscalpel 320 by transducer 350 and/or conductor 336; is noted the general method shown in Fig. 3 shows a transfer of energy to a stenosis that is part of/ formed on the vessel wall).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the applicant’s claimed invention to modify the scaffold associated with claim 1 of U.S. Patent No. 12,268,410 such that the scaffold is electrically conductive and configured to transfer energy or electrical pulses to the vessel wall according to the teachings of Miller because it would allow for incising stenosis at lower dilatation pressures, or to incise stenosis that are difficult to incise utilizing conventional cutting balloons, thereby reducing trauma to the vessel wall, as well as any subsequent restenosis that can result therefrom (Miller - - Ps. [0030], [0032], [0046], [0047]).
Application claim 19 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,268,410 in view of Goeken et al. (US Pub. No. 2007/0060863 A1).
Regarding application claim 19, Application claim 2 is obvious over claim 1 of U.S. Patent No. 12,268,410, but claim 1 of U.S. Patent No. 12,268,410 does not claim
(application claim 19) wherein the shape of the non-continuous scoring element comprises one or more of a pointed, triangular, or rectangular shape
However, Goeken teaches a method of treating a target site within a vascular lumen while diminishing injury to a vascular site in the same field of endeavor (P. [0002] - - Balloon catheters can be used for a variety of medical procedures such as, for example, to widen an occluded body vessel, as in angioplasty … Initially, the balloon is folded around the catheter body to reduce the radial profile of the balloon catheter for easy insertion into the body; it is noted reduced radial profile/ easy insertion into the body is interpreted as diminishing injury to a vascular site)
(application claim 19) wherein the shape of the non-continuous scoring element (105) (Figs. 1- 6) comprises a triangular shape (Ps. [0039], [0055] - - Cutting elements 105 are elongated members (e.g., steel blades) having a triangular cross-section in which the base is attached to balloon 102 and a cutting edge is formed at the apex of the triangular section; Cutting elements 105 can extend continuously and/or non-continuously along portions of balloon 102. For example, a cutting element line can be formed of a plurality of cutting elements arranged end to end. Combinations of different spacings, configurations and/or dimensions are possible. Cutting elements 105 can have smooth and/or jagged, e.g., serrated, cutting edges).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the applicant’s claimed invention to modify the shape of the non-continuous scoring element associated with claim 1 of U.S. Patent No. 12,268,410 to comprise a triangular shape according to the teachings of Goeken because it would allow a cutting edge to form at the apex of the triangular section (Goeken - - Ps. [0039], [0055]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KANKINDI RWEGO whose telephone number is (303)297-4759. The examiner can normally be reached Tuesday- Wednesday 9:00a- 5:30 PST.
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/KANKINDI RWEGO/ Primary Examiner, Art Unit 3771
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