DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on April 10, 2026 has been entered.
Currently, claims 1 and 5-22 are pending with claims 2-4 cancelled, claims 8-13 and 15-22 withdrawn, and claim 1, 5 and 6 amended. The following is a complete response to the April 10, 2026 communication.
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 .
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 7 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.
Regarding claim 7, the claim first recites the limitation of “the guidewire comprises a main wire extending between the proximal portion and the distal portion”. This limitation renders the scope of the claim as indefinite because parent claim 1, as amended, already recites “a main wire extending between the proximal portion and the distal portion”. Thus, the Examines is of the position that the scope of claim 7 is indefinite because it is, at most, unclear if the main wire of claim 7 is the same wire as that set forth in claim 1, or is directed towards a materially different and distinct main wire.
Claim 7 further recites “the main wire is the radially expandable part”. The requirement of “the radially expandable part” fails to have proper antecedent basis in the claims especially in view of the amendments made to parent claim 1 to remove the language of “at least one part that is radially expandable”. The Examiner further finds that this limitation renders the scope of the claims unclear and confusing given that various other structures of the main wire (tines) have already been described as functioning to flex radially outward in claim 1. Appropriate correction is required.
Regarding claim 14, the claim recites that “the part is biased toward the expanded configuration”. First, “the part” fails to have proper antecedent basis in the claims. Next, the recitation of “the part” renders the scope of the claim as indefinite because there is no clear structural relationship of “the part” to any of the previously-recited structure in independent claim 1. Appropriate correction is required.
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.
Claims 1, 5, 7, and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Weber (US Pat. Pub. 2013/0116715 A1).
Regarding claim 1, Weber provides for a medical device comprising:
a guidewire extending between a proximal portion defining a proximal end and a distal portion defining a distal end (see the inner structure of the device 10 passing through 20 as in figure 2),
wherein the guidewire comprises a main wire extending between the proximal portion and the distal portion (42), and a sleeve on the main wire in the distal portion (44), the sleeve comprising a plurality of tines that are circumferentially spaced apart (46), and the guidewire is movable between a retracted configuration in which the tines lie generally flat and an expanded configuration in which the tines flex radially outwardly (see [0056] providing for the “collapsed delivery configuration of the wires 46 to an expanded configuration as shown in figure 2),
wherein the distal portion is biased toward the expanded configuration, such that it is automatically movable from the retracted configuration to the expanded configuration upon the tines clearing an introducer (See [0034] providing for the wires to be formed of “a shape memory material … configured to automatically expand into the deployed or expanded cutting … configuration”), and
wherein the tines are configured to conform to contours of a pericardial space when in the expanded configuration (via the disclosed in [0034] of 46 being formed of a flexible member capable of bending).
Weber, while providing for various portions of the device to be radiopaque including portions at the distal end of the device (see [0053] providing for 44/54/70 to be radiopaque) fails to specifically provide that the tines are radiopaque. Mowery provides that it is known to coat extendable tines of a device with a radiopaque material (see [0121] providing for markers 128 to be coated on to tines 120/121). Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time of filing to have coated at least a portion of each of 46 of Weber with a radiopaque material in view of the teaching of Mowery to provide an alternative manner of visualizing the location of the distal end portion of the device of Weber during use within the body.
Regarding claim 5, Weber provides that the guidewire further comprises a retainer on the sleeve (400), wherein the retainer comprises a plurality of apertures (420), and
when the guidewire is in the retracted configuration, the tines are held within the retainer (see [0055] providing for each slots to be dimensioned to accommodate a respective wire 46),and wherein when the guidewire is in the expanded configuration, the tines extend through the apertures and away from the sleeve (as shown in figure 2).
Regarding claim 7, Weber provides that the guidewire comprises a main wire extending between the proximal portion and the distal portion, and the main wire is the radially expandable part (view the various structural features and functions as set forth in the rejection of claim 1 above).
Regarding claim 14, Weber provides that a part of the device is biased towards the expanded configuration (via, for example the wires 46 as relied upon in the rejection of claim 1 above being formed of a shape-memory material).
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 6 is rejected under 35 U.S.C. 103 as being unpatentable over Weber (US Pat. Pub. 2013/0116715 A1) as applied to claim 1 above, and further in view of Pearson et al. (US Pat. Pub. 2005/0240174 A1).
Regarding claim 6, Weber fails to provide that the main wire comprises an electrical conductor and an electrically insulative material on the electrical conductor, and the guidewire further comprises an electrode at the distal end. Pearson discloses a similar device as that of Weber and specifically provides for an electrode contained at the distal end of a guidewire (122 at the distal end of 22; see [0033]). Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time of filing to have utilized an electrode at the distal end of the guidewire such as on the tip of 30 or at 44 in Weber in view of the teaching of Pearson to provide for a distal end portion that can provide an additional functionality such as energy application or sensing during introduction and treatment via the guidewire. In providing such a modification, the Examiner finds that it would have been a matter of routine skill to one in the art to have provided for an insulated electrical conductor along the main wire to provide for the requisite electrical connection from the electrode of the combination to the proximal end of the device.
Response to Arguments
Applicant’s arguments, see pages 7-10 of the Remarks filed April 10, 2026, with respect to the rejection of claim 1 under 35 U.S.C. 103 as unpatentable over the combination of Habib, Schaefer and Waldhauser have been fully considered and are persuasive. Specifically, the Examiner fails to find that the prior combination provides for each and every limitation as set forth in the amended version of independent claim 1. Therefore, the prior rejections under 35 U.S.C. 103 based on the combination of Habib, Schaefer and Waldhauser have been withdrawn. However, upon further consideration, the following new grounds of rejection have been set forth in the action above:
Claims 7 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.
Claims 1, 5, 7, and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Weber (US Pat. Pub. 2013/0116715 A1).
Claims 6 is rejected under 35 U.S.C. 103 as being unpatentable over Weber (US Pat. Pub. 2013/0116715 A1) as applied to claim 1 above, and further in view of Pearson et al. (US Pat. Pub. 2005/0240174 A1).
It is the Examiner’s position that the newly proffered grounds of rejection are tenable for at least the reasoning set forth in the Action above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RONALD HUPCZEY, JR whose telephone number is (571)270-5534. The examiner can normally be reached Monday - Friday; 8 am - 4 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joseph Stoklosa can be reached at (571) 272-1213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Ronald Hupczey, Jr./Primary Examiner, Art Unit 3794
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