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 .
Election/Restrictions
Applicant's election with traverse of Group I and Species C in the reply filed on 14 July 2025 is acknowledged. The traversal is on the ground(s) that there is not a serious search burden on the examiner because the field of search would be substantially coextensive between the non-elected and elected inventions and species. This argument is found partially persuasive. Upon reconsideration, the election requirement is withdrawn in part, as the field of search for Species C (Fig. 13B) and Species D (Fig. 13C) is found to be similar. The restriction requirement between the inventions of Group I and Group II is maintained, and the election requirement is reinstated between the following species:
Species A: Back support in form of cantilevered beam as shown in Fig. 3
Species B: Back support in form of member supported by wires as shown in Fig. 13A
Species C: Back support in form of support wires or mesh as shown in Figs. 13B-C
Species D: Back support in form of film body as shown in Fig. 13D
Claims 8-9, 12, and 17-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention and species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 14 July 2025.
Claim Objections
Claim 15 is objected to because of the following informalities: in line 3, “back support” should read --back support wires--. 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.
Claims 2-7, 10-11, and 14 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.
In claims 2 and 14, the limitation “and a direction orthogonal to the radial direction of the expansion body” is unclear because it is unclear how an element can be orthogonal to both the axis of the expansion body and the plane defined by radial expansion, which is itself orthogonal to the axis. For examination purposes, the claims will be read without this limitation. Dependent claims 3-7 and 10-11 are necessarily rejected as depending upon a rejected base claim.
In claim 6, the term “larger” in the limitation “the back support portion moves larger than the two outer peripheral portions” is unclear. For examination purposes, this limitation will be read as wherein the back support portion moves further than the two outer peripheral portions.
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)(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 1-5 and 7 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Arevalos et al. (US PGPub No. 2020/0289196), hereinafter Arevalos.
Regarding claim 1, Arevalos discloses a medical device comprising: an elongated shaft portion (Fig. 1: delivery catheter 201);
and an expansion body that is provided in a distal portion of the shaft portion, the expansion body configured to expand and contract in a radial direction, wherein the expansion body includes a plurality of wire portions that are linked with the shaft portion (Figs. 18A-18C: self-expanding mesh 1803; par. 0188: “a self-expanding (shape memory) mesh 1803o in the shape of a dumbbell […] the discs are constrained within a delivery catheter and unconstrained to permit expansion on either side of the septum 1807”),
and at least one clamping portion that is formed by at least one of the wire portions (Fig. 18C: discs clamping onto septum 1807),
the clamping portion includes an energy transfer element configured to output energy (Figs. 18B-18C: proximal disc of mesh 1803o; par. 0188: “flexible metal loops are mounted on the inward faces (septum-facing sides) of each mesh disc, or alternatively, on around curved face of each disc (set back with respect to the face contacting the septum). In some embodiments, the discs are constrained within a delivery catheter and unconstrained to permit expansion on either side of the septum 1807. In some embodiments, the metal loops act as the RF cathode 1803b and anode 1813b”),
and a back support portion, the back support portion includes a receiving surface that is configured to face the energy transfer element when the expansion body expands (Figs. 18B-18C: distal disc of mesh 1803o),
and the receiving surface is configured to be inclined to be approximately parallel to the energy transfer element, when the energy transfer element moves toward the back support portion (par. 0188: “the discs serve to ensure and maintain parallel alignment of the metal loops with septum”).
Regarding claims 2-4, Arevalos discloses the device of claim 1 as described previously. Arevalos further discloses wherein the at least one clamping portion includes two outer peripheral portions on both sides in a width direction that is a direction orthogonal to an axial direction of the expansion body relative to the back support portion, wherein the two outer peripheral portions each have a convex shape to an outer side in the width direction, and wherein the two outer peripheral portions each have a circular arc shape that smoothly projects to the outer side in the width direction (Fig. 18B: circular shape of memory mesh 1803o orthogonal to axis of catheter, with left and right sides of the circular shape projecting in a convex circular arc shape).
Regarding claim 5, Arevalos discloses the device of claim 2 as described previously. Arevalos further discloses wherein a maximum width between the two outer peripheral portions that sandwich the back support portion between the two outer peripheral portions in the width direction is larger than a maximum width of the energy transfer element in the width direction (Figs. 18B-18C: maximum width of mesh 1803o wider than maximum width of metal loops 1803b and 1813b).
Regarding claim 7, Arevalos discloses the device of claim 2 as described previously. Arevalos further discloses wherein the expansion body includes an inner projection portion that projects to an inner side in the radial direction between the energy transfer element and the back support portion; and the maximum width between the two outer peripheral portions that sandwich the back support portion between the two outer peripheral portions in the width direction is larger than a maximum width of the inner projection portion in the width direction (Figs. 18A-18C: maximum width of dumbbell-shaped mesh 1803o wider than the inner connecting portion passing through septum 1807).
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 6, 10-11, and 13-16 are rejected under 35 U.S.C. 103 as being unpatentable over Arevalos in view of Nezhat (US Patent No. 6,123,701).
Regarding claims 6 and 10-11, Arevalos teaches the device of claim 2 as described previously. Arevalos does not explicitly teach wherein the back support portion moves further than the two outer peripheral portions due to a force in the axis direction to be received from the energy transfer element, or wherein the back support portion is at least one flexible back support wire or a mesh-like member that extends from the two outer peripheral portions that sandwich the back support portion between the two outer peripheral portions. However, in an analogous art, Nezhat teaches a tissue-clamping device with two outer peripheral portions (Figs. 1D-1E: frame structure around electrode 202) with a back support portion comprising at least one flexible back support wire or a mesh-like member sandwiched therebetween (Figs. 1D-1E: conformable mesh electrode structure 202; col 7, lines 29-30: “The conformable electrode structures 202 and 203 comprise metallized elastomeric meshes”), wherein the back support portion moves further than the two outer peripheral portions due to a force in the clamping direction (Fig. 1E: mesh electrode 202 extending beyond frame structure when force is applied for clamping), which assures firm engagement and electrode contact with the tissue (col 3, lines 37-41: “it will be desirable to provide flexible, elastic electrodes which may be conformed about the outer periphery of a tissue or organ surface, where the elastic nature of the electrode assures firm engagement and electrode contact”). Nezhat is considered analogous to the claimed invention because it is reasonably pertinent to the problem faced by the inventor, that is, the problem of establishing firm electrode contact with tissue. It would therefore have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to provide the device of Arevalos with a flexible back support portion, as taught by Nezhat, in order to assure firm engagement and contact with tissue, as taught by Nezhat.
Regarding claim 13, Arevalos in view of Nezhat teaches the limitations of the claim for the same reasons set forth in the rejections of claims 1-2 and 10.
Regarding claim 14, the combination teaches the device of claim 13 as described previously. Arevalos further teaches the limitations of claim 14 for the same reasons set forth in the rejection of claim 2.
Regarding claims 15-16, the combination teaches the device of claim 13 as described previously. Nezhat further teaches wherein the at least one flexible back support wire comprises a plurality of back support wires, the plurality of back support having both ends fixed to the two outer peripheral portions, and wherein the receiving surface of the back support portion is formed by the plurality of the back support wires with gaps (Fig. 1D: mesh electrode 202 comprising a plurality of wires with gaps between the wires).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVINA E LEE whose telephone number is (571)272-5765. The examiner can normally be reached Monday through Friday between 8:00 AM and 5:30 PM (ET).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, LINDA C DVORAK can be reached at 571-272-4764. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/D.E.L./Examiner, Art Unit 3794