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 .
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 expandable member mounted adjacent and coextensive to said device (claims 1 and 12) 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 Interpretation
In regards to claims 1 and 12, the claims read “a device comprising a locator element, carried by said flexible elongate delivery device along a distal end of said flexible elongate delivery device for deployment at the target site” [claim 1, lines 6-7, claim 12, lines 7-8]. It is clear this means the device is carried and is for deployment at the target site, and not just the locator element.
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 1-7, 10-13 and 15 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 regards to claim 1, the claim reads “a flexible elongate delivery device having a distal end” [line 3] and “a distal end of said flexible elongate delivery device” [lines 6-7]. It is unclear if these are recitations of the same item. Therefore, the claim is unclear. For the purposes of prosecution, it will be assumed these are the same item.
In regards to claim 12, the claim reads “a flexible elongate delivery device having a distal end” [line 4] and “a distal end of said flexible elongate delivery device” [lines 7-8]. It is unclear if these are recitations of the same item. Therefore, the claim is unclear. For the purposes of prosecution, it will be assumed these are the same item.
Response to Arguments
Rejection under 35 U.S.C. 102(a)(2) as anticipated by Nedved et al. (US 2023/0000550).
Argument:
In regards to the amended claim 1, the applicant argues that Nedved does not teach a device navigable within a patient’s gastrointestinal anatomy, as Nedved instead teaches a device navigable in the circulatory system [in the applicant's arguments dated 16 March, 2026, page 7].
Response:
The examiner respectfully disagrees. This disclosure by Nedved does not prevent the device of Nedved from being deployed in gastrointestinal anatomy. Nothing about the device of Nedved prevents it from being used there.
As such, this argument is found to be unconvincing.
Rejection under 35 U.S.C. 102(a)(1) as anticipated by Phan et al. (US 2011/0112622).
Argument:
In regards to the amended claims 1 and 12, the applicant argues that Phan does not teach an expandable member mounted adjacent and coextensive to a device comprising a locator element [in the applicant's arguments dated 16 March, 2026, page 8].
Response:
The examiner respectfully disagrees.
“Coextensive” means having the same spatial or temporal scope or boundaries. Phan has been reinterpreted such that the device has at least one spatial extent in common with the expandable member.
As such, this argument is rendered moot by different application of the art.
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(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 1-7 and 10-11 are rejected under 35 U.S.C. 102(a)(2) as anticipated by Nedved et al. (US 2023/0000550).
In regards to Claim 1, Nedved discloses a system navigable within a patient's gastrointestinal anatomy to a target site within the patient, said system comprising:
a flexible elongate delivery device [123, 303, Figs.3-5, para.48-49] having a distal end navigable within the patient's gastrointestinal anatomy [para.4, 12, 48, further suitable to be navigated to an intracardiac target; this could be chosen to be navigated in gastrointestinal anatomy] and a proximal end accessible for navigating said flexible elongate delivery device [123, Fig.3a, para.48];
a device [a portion of 107 having the same length as 109 in its elongated configuration in Fig.5, see Figs.3-5, para.44] comprising a locator element [note the breadth of this limitation: any part of 107 could be used as a locator element], carried by said flexible elongate delivery device along a distal end of said flexible elongate delivery device for deployment at the target site; and
an expandable member [409, Fig.4, para.48, 70] mounted adjacent and coextensive [as defined hereinabove] to said device and shiftable between a delivery configuration and an expanded configuration with a cross-sectional dimension greater than the delivery configuration.
In regards to Claim 2, Nedved discloses the system of claim 1, wherein said expandable member comprises one or more flexible elongated elements [413, 415, Figs.4-5, para.70] shiftable from a generally elongated delivery configuration [Fig.5] to the expanded configuration [Fig.4, para.70].
In regards to Claim 3, Nedved discloses the system of claim 2, wherein said one or more flexible elongated elements are bowed or curved when in the expanded configuration [Fig.4].
In regards to Claim 4, Nedved discloses the system of claim 2, wherein said one or more flexible elongated elements are formed of a shape memory material [para.99, 101: conductive wires may be made of Niti and may be part of the basket assembly] configured to shift said expandable member into the expanded configuration upon application of force thereto and to return said expandable member to the delivery configuration upon removal of the force therefrom [para.70].
In regards to Claim 5, Nedved discloses the system of claim 2, wherein said flexible elongate delivery device comprises a flexible tubular element [303, Fig.4] and an actuator [301, Fig.4, para.48] extending through said flexible tubular element, said actuator being coupled to said expandable member to shift said expandable member between the delivery configuration and the expanded configuration upon axial translation of said actuator [Fig.4, para.48-49].
In regards to Claim 6, Nedved discloses the system of claim 5, wherein proximal ends of said one or more flexible elongated elements are coupled to a distal end of said flexible tubular element [Figs.4-5], and distal ends of said one or more flexible elongated elements are coupled to said actuator [Figs.4-5].
In regards to Claim 7, Nedved discloses the system of claim 6, wherein proximal retraction of said actuator causes said one or more flexible elongated elements to expand said expandable member into the expanded configuration [Figs.4-5, para.48-49].
In regards to claim 10, Nedved discloses the system of claim 1, wherein said expandable member is mounted adjacent the distal end of said flexible elongate delivery device [Figs.4-5], said system further comprising a locator element mounted along or adjacent the distal end of said flexible elongate delivery device [Figs.4-5, any portion. Note that the applicant has not provided a strict definition of “locator element”].
In regards to claim 11, Nedved discloses the system of claim 1, wherein said expandable member is expandable to have a diameter at least half an inner diameter of a body passage through which said system is to be navigated [Fig. 10, also if given an appropriate lumen].
Claims 1-3, 10-13 and 15 are rejected under 35 U.S.C. 102(a)(1) as anticipated by Phan et al. (US 2011/0112622).
In regards to claim 1, Phan discloses a system navigable within a patient's gastrointestinal anatomy to a target site within the patient, said system comprising:
a flexible elongate delivery device [100, Figs.4-6] having a distal end [102, 112, Figs.4-6, para.43; this could be navigated in gastrointestinal anatomy] navigable within the patient's gastrointestinal anatomy and a proximal end [104, Fig.4, para.44] accessible for navigating said flexible elongate delivery device;
a device [a portion of 122 having the same length as 118 when 118 is in elongated configuration in Fig.5a, see Figs.5-6, para.43] comprising a locator element [any part of 122 could be used as a locator element, noting the breadth of this limitation], carried by said flexible elongate delivery device along a distal end of said flexible elongate delivery device for deployment at the target site; and
an expandable member [118, Figs.5-6, para.43, 46] mounted adjacent and coextensive to [as defined hereinabove] said device and shiftable between a delivery configuration and an expanded configuration with a cross-sectional dimension greater than the delivery configuration.
In regards to Claim 2, Phan discloses the system of claim 1, wherein said expandable member comprises one or more flexible elongated elements [Portions of 118, Figs.5-6] shiftable from a generally elongated delivery configuration [Fig.5b] to the expanded configuration [Fig.5c, para.43].
In regards to Claim 3, Phan discloses the system of claim 2, wherein said one or more flexible elongated elements are bowed or curved when in the expanded configuration [Figs.5-6].
In regards to claim 10, Phan discloses the system of claim 1, wherein said expandable member is mounted adjacent the distal end of said flexible elongate delivery device [Figs.5-6], said system further comprising a locator element mounted along or adjacent the distal end of said flexible elongate delivery device [Figs.5-6, any portion of 102, 112. Note that the applicant has not provided a strict definition of “locator element”].
In regards to claim 11, Nedved discloses the system of claim 1, wherein said expandable member is expandable to have a diameter at least half an inner diameter of a body passage through which said system is to be navigated [Fig.6c, also if given an appropriate lumen].
In regards to claim 12, Phan discloses a system navigable within a patient's anatomy to a target site within the patient, said system comprising:
an endoscope [E, Fig.6, para.44] with a working channel [para.44] extending therethrough;
a flexible elongate delivery device [100, Figs.4-6] having a distal end [102, 112, Figs.4-6, para.43] extendable distally out of the working channel of said endoscope [Fig.6] and navigable within the patient's anatomy and a proximal end [104, Fig.4, para.44] accessible for navigating said flexible elongate delivery device;
a device [a portion of 122 having the same length as 118 when 118 is in elongated configuration in Fig.5a, see Figs.5-6, para.43] comprising a locator element [any part of 122 could be used as a locator element, noting the breadth of this limitation], carried by said flexible elongate delivery device along a distal end of said flexible elongate delivery device for deployment at the target site; and
an expandable member [118, Figs.5-6, para.43, 46] mounted adjacent and coextensive to [as defined hereinabove] said device and shiftable between a delivery configuration and an expanded configuration with a cross-sectional dimension greater than the delivery configuration.
In regards to claim 13, Phan discloses the system of claim 12, wherein said expandable member comprises one or more flexible elongated elements [portions of 118, Figs.5-6] shiftable from a generally elongated delivery configuration to the expanded configuration.
In regards to claim 15, Phan discloses the system of claim 12, wherein said expandable member is mounted adjacent the distal end of said flexible elongate delivery device [Figs.5-6], said system further comprising a locator element [Figs.4-6, any portion of 102, 112. Note that the applicant has not provided a strict definition of “locator element”] mounted along or adjacent the distal end of said flexible elongate delivery device.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Keast et al. (US 2012/0289776)
Applicant's amendment necessitated the new ground(s) of rejection (altered interpretation of art) presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AARON B FAIRCHILD whose telephone number is (571)270-5276. The examiner can normally be reached 8:30am-5pm Monday-Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Carey can be reached at (571) 270-7235. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AARON B FAIRCHILD/Primary Examiner, Art Unit 3795
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