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) filed March 18, 2024 has been entered and the references cited therein have been considered by the examiner.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the balloon member attached to the distal portion of the hub (claim 11) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) 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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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 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 11-18 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 11 recites “a balloon member attached to the distal portion of the hub.” Since claim 11 recites both a sheath hub and a dilator hub, the claim is not clear at to which hub is being referenced in the final paragraph of the claim. Furthermore, the final paragraph of the claim goes on to recite that the balloon member transitions from a deflated state adapted for delivery through the sheath to an inflated state when positioned distal to the sheath. This is only possible when the balloon is attached to the distal end of the dilator body, not the distal end of the dilator hub. Thus, for examination purposes, it was assumed that applicant intended to recite “dilator body” instead of either sheath hub or dilator hub in the final paragraph of claim 11.
As claims 12-18 depend from claim 11, they are likewise rejected.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 16 rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 16 recites a “perforation device” while claim 11, from which claim 16 depends, recites a “puncturing device.” Para. 0003 of the specification describes that a device is provided for puncturing or perforating the septum. Thus, it is assumed that there is only one device (a perforation device as described in detail in the specification) that performs the puncturing. In response, the Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 (i.e., changing from AIA to pre-AIA ) 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.
Claim(s) 1, 2, 4-11 and 13-20 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Lenker et al. (U.S. Patent Application Publication No. 2023/0107208).
In regard to claims 1, 2, 10 and 11, Lenker et al. teach an introducer system 1600 used to penetrate the interatrial septum of the heart (see para. 0004) comprised of an axially elongate sheath 1602 having a sheath wall 1604, a central lumen and a sheath hub 1608 (see Fig. 11A and para. 0082). The introducer system 1600 also includes a dilator 1620 that has a proximal end portion and an opposite distal end portion where the distal end portion has a tapered distal tip 1628 and the dilator 1620 is received in the central lumen of the sheath 1602 (see Figs. 11A and 11B and para. 0082). Dilator 1620 has at least one lumen 1626 configured to accept guidewires, permit fluid passage or slidably pass the steerable access system (SAS), etc. (see para. 0082). Thus, dilator 1620 has a cylindrical wall defining an inner surface where the inner surface defines the lumen 1626 and Figure 11B shows that the lumen 1626 extends the entire length of the dilator 1620. Figure 11B also shows that the dilator 1620 has an outer surface having an outer diameter. Lenker et al. also teach an expandable enlargement 1612 affixed to or integrally to the exterior of the dilator 1620 (see Figs. 11A and 11B and para. 0082). The expandable enlargement 1612 can be controllably enlarged and can reduce in diameter and can be an expandable balloon (expandable membrane) (see para. 0082). Figure 11A demonstrates that the expandable enlargement 1612 is delivered through the sheath 1602 and expands when positioned distal to the sheath 1602. In regard to claims 4-6 and 13-15, Lenker et al. teach that radial enlargement of the expandable enlargement 1612 can occur due to pressurization or inflation by means of a fluid port on the proximal end and a fluid channel leading to a balloon (see para. 0082). With further respect to claim 11 and in regard to claims 7-9 and 16-18, Lenker et al. teach that the lumen 412 (1626) in the dilator 404 (1620) can house an electrical wire that connects to an electrode 410 proximate the distal tip of the dilator to generate energy and promote tissue penetration (see para. 0047 and Fig. 1). In regard to claims 19 and 20, it should be noted that it has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Ex parte Masham, 2 USPQ2d 1647 (1987). Also, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). In In re Crish, 393 F.3d 1253, 1258, 73 USPQ2d 1364, 1368 (Fed. Cir. 2004). Thus, if the prior art structure is capable of performing the intended use, then it meets the claim. In the instant application, the structure of Lenker et al. is capable of performing the method steps of “making a dilator” which essentially means assembling the structural elements.
a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art.
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 (i.e., changing from AIA to pre-AIA ) 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.
Claim(s) 3 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lenker et al. (U.S. Patent Application Publication No. 2023/0107208) in view of Alexander et al. (U.S. Patent Application Publication No. 2002/0142652).
In regard to claims 3 and 12, Lenker et al. are silent as to the material makeup of the expandable enlargement 1612 as a balloon. However, Alexander et al. teach a medical expansion component 420 that is a balloon adapted for dilation where the expansion component 420 is comprised of a balloon constructed from polyurethane or PEBAX (see para. 0044 and Fig. 4). Alexander et al. thus demonstrate that the use of polyurethane or PEBAX as the material for an expandable medical balloon is well known in the art. Furthermore, it is well settled that the selection of a known material based on its suitability for its intended use is an obvious design selection for one of ordinary skill in the art. See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945); In re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960). Accordingly, it would have been an obvious matter of design choice for one of ordinary skill in the art at the effective filing date of the invention to fabricate the expandable enlargement 1612 as a balloon of Lenker et al. from either the polyurethane or the PEBAX disclosed by Alexander et al.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BEVERLY MEINDL FLANAGAN whose telephone number is (571)272-4766. The examiner can normally be reached Mon-Fri 7:30AM to 5:00PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Linda 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.
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/BEVERLY M FLANAGAN/Primary Examiner, Art Unit 3794