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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 9/8/23;7/8/25 are in compliance with the provisions of 37 CFR 1.97(b). Accordingly, the IDSs are being considered by the Examiner.
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.
Claims 1-32 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-32 of U.S. Patent No. 11,690,978. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the application which are broader than the claims in the patent are anticipated by the patented claims.
Claim Objections
Claim 10 is objected to because of the following informalities: should depend from claim 9, not claim 1. Appropriate correction is required.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 6-8, 17-18, 20-21, 23, 25-28, 30-31 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Tropello (US 2020/0214661). Tropello discloses:
Claims 1,21,27,31: A method of forming and the catheter 110 formed, Fig. 2 comprising: an elongate body extending along a longitudinal axis from a proximal end to a distal end and defining a lumen extending longitudinally within the elongate body, the elongate body comprising a proximal portion and a distal portion; and an echogenic member 124 (balloon 124 provides an echogenic space [0037]) positioned on the distal portion of the elongate body, wherein the echogenic member is configured to controllably expand from a collapsed configuration to an expanded configuration [0041], and wherein the echogenic member is configured to diffusely scatter a soundwave, see claim 17. The method of use identifies at least one of a position, orientation or trajectory of the distal portion of the catheter relative to the selected location based on a soundwave reflected by the echogenic member (second component)—see claim 25.
Claims 21,27,31: kit, see [0016]; medical device for therapy delivery or sensing out of the distal end of the elongate body 122, see [0011-0012]
Claims 2, 28: the echogenic member 124 (balloon) comprises balloon inflatable [0041] from the collapsed configuration to the expanded configuration and deflatable (step 809, Fig. 8 [0048]) from the expanded configuration to the collapsed configuration.
Claim 3: the echogenic member 124 comprises at least one of a self-expanding member or controllably expanding member (via syringe 118).
Claim 6: the echogenic member 124 is positioned between about 0 mm and about 5 mm from the distal end 120 of the elongate body. Fig. 2
Claim 7: a shape of the echogenic member 124 is a shape selected from the group including a sphere, an ellipse, and a frustum. See Fig. 2 ([0040], balloon may be formed in varying shapes and sizes)
Claim 8: the echogenic member 124 comprises a distal end and a proximal end, each coupled to an external surface of the elongate member, wherein the echogenic member is tapered toward the longitudinal axis at at least one of the distal end or the proximal end of the echogenic member. See Fig. 7
Claims 20, 26: further comprising a handle assembly (at 112, anything that you can grip can be considered a handle) having a control member (118, syringe), wherein the handle assembly is configured to controllably expand the echogenic member from the collapsed configuration to the expanded configuration. [0041]
Claim 23: the echogenic member 124 is configured to be inflated with the echogenic fluid. [0040]
Claim 30: wherein identifying at least one of the position, the orientation, or the trajectory of the distal portion comprises: imaging, by an ultrasound imaging device, the at least one echogenic member; and determining, based on the ultrasound image, at least one of the position, the orientation, or the trajectory of the distal portion relative to an anatomy of the patient surrounding the distal portion of the catheter. See claims 25, 29, Fig. 1
Claims 17, 18, 25: wherein the lumen (distal end of elongate body) is configured to receive an implantable medical electrical lead comprising at least one electrode. See [0011-0013]
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Tropello.
Tropello discloses the invention as substantially claimed but does not directly disclose the collapsed and expanded diameters of the echogenic member 124. The balloon of Tropello is used in various tissue planes and cavities in a patient’s body, including by way of non-limiting example the thorax, abdomen, blood vessels, pericardium, stomach [0011]. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have a diameter of the echogenic member less than about 9.5 millimeters (mm) in the collapsed configuration and a diameter of the echogenic member within a range between about 1 mm and about 30 mm when in the expanded configuration since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233 (CCPA 1955).
Claims 9-16, 19, 22, 24, 32 are rejected under 35 U.S.C. 103 as being unpatentable over Tropello in view of Drasler et al. (US 2015/0306359) (“Drasler”).
Tropello discloses the invention as substantially claimed but does not directly disclose the echogenic member (balloon) 124 comprising an (claims 9, 22, 32) echogenic coating. Drasler, in the analogous art, teaches coating a balloon (Fig. 8d) with a thin film of echogenic material in a (claim 10) polymeric suspension [0062,0064]
The echogenic member of Tropello or Drasler is configured to be (claim 11) inflated with an echogenic fluid (any fluid can inflate the balloon and Tropello directly discloses this fluid being an echogenic fluid; also, as described in Drasler, air is an echogenic fluid [0027]).
With regard to claim 12, Drasler also teaches there being a radiopaque marker (RO) 113 on the distal portion of the elongate body—Drasler teaches using both RO and echogenic coatings and markers.
With regard to claims 13-15, 24, Drasler teaches having first and second echogenic members on the distal portion of the elongate body. The members 104a,104c can be constructed of a variety of materials and wall dimensions to provide a difference in compliance [0041] contributing to different sizes and shapes, Figs. 2a,2b. The second echogenic member is within a range from about 5mm to about 25mm proximal to the first echogenic member, see Figs. 2a,b (19 provides spacing between the members)
With regard to claim 19, Drasler directly teaches that the soundwave comprises an ultrasonic soundwave having a frequency within range from about 1 megahertz (MHz) to about 20 MHz [0027].
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the echogenic member 124 of Tropello with the balloon 104 as these elements are simple substitutions that perform the same function.
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Tropello in view of Tandri et al. (US 10,842,556) (“Tandri”).
Tropello discloses the invention as substantially claimed but does not directly disclose the handle having a pull wire, and wherein expanding the echogenic member comprises actuating the control member to cause the pull wire to expand the echogenic member. Tandri, in the analogous art, teaches a stabilizing balloon or cage C16L18-36 that is deployed by applying tension to a pull wire connected to the stabilization mechanism C17L30-50. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the echogenic member at the distal end of Tropello with the stabilizing device as taught by Tandri that is expanded and collapsed via a pull wire rather than a syringe as another well known way to operate a stabilization device without the need for inflation lumens.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEANNA K HALL whose telephone number is (571)272-2819. The examiner can normally be reached M-F 8:30am- 4:30pm EST.
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/DEANNA K HALL/Primary Examiner, Art Unit 3783